抗体药研发问答403~406 || 杂质安全系数（ISF）评估
<div style="max-width:677px;overflow:hidden;"><section style="margin: 0px;padding: 0px;outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;color: rgb(34, 34, 34);font-size: 17px;font-style: normal;font-variant-ligatures: normal;font-variant-caps: normal;font-weight: 400;letter-spacing: 0.544px;orphans: 2;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 2;word-spacing: 0px;-webkit-text-stroke-width: 0px;text-decoration-thickness: initial;text-decoration-style: initial;text-decoration-color: initial;font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;background-color: rgb(255, 255, 255);visibility: visible;"><span style="text-indent: 0em; letter-spacing: 0.544px; outline: 0px; max-width: 100%; color: rgb(0, 122, 170); font-family: "Microsoft YaHei", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; font-size: 16px; box-sizing: border-box !important;"><strong style="outline: 0px; max-width: 100%; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; letter-spacing: 1px; box-sizing: border-box !important;">♂</span></strong></span><span style="text-indent: 0em; letter-spacing: 0.544px; outline: 0px; max-width: 100%; text-align: left; box-sizing: border-box !important;"><strong style="outline: 0px; max-width: 100%; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; color: rgb(0, 122, 170); font-family: "Microsoft YaHei", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; letter-spacing: 0.5px; font-size: 16px; box-sizing: border-box !important;">Q</span><span style="outline: 0px; max-width: 100%; font-size: 15px; color: rgb(0, 0, 0); font-family: Arial, sans-serif; box-sizing: border-box !important;">403</span></strong></span><span style="text-indent: 0em; letter-spacing: 0.544px; outline: 0px; max-width: 100%; color: rgb(0, 122, 170); font-family: "Microsoft YaHei", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; text-align: left; box-sizing: border-box !important;"><strong style="outline: 0px; max-width: 100%; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; letter-spacing: 0.5px; font-size: 16px; box-sizing: border-box !important;"> </span></strong></span><span style="text-indent: 0em; letter-spacing: 0.544px; outline: 0px; max-width: 100%; color: rgb(0, 122, 170); font-family: "Microsoft YaHei", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; text-align: left; box-sizing: border-box !important;"><strong style="outline: 0px; max-width: 100%; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; letter-spacing: 0.5px; font-size: 16px; box-sizing: border-box !important;">ISF评估的前提背景是什么？</span></strong></span></section><section 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center;box-sizing: border-box !important;overflow-wrap: break-word !important;"><section style="margin: 0px;padding: 0px;outline: 0px;max-width: 100%;user-select: auto;max-inline-size: 100%;line-height: 1.6;justify-content: center;box-sizing: border-box !important;overflow-wrap: break-word !important;"><section style="color: rgb(34, 34, 34);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;font-size: 17px;font-weight: 400;margin: 0px;padding: 0px;outline: 0px;max-width: 100%;white-space: normal;letter-spacing: 0.544px;user-select: auto;max-inline-size: 100%;line-height: 1.6;justify-content: center;box-sizing: border-box !important;overflow-wrap: break-word !important;"><section style="margin: 0px;padding: 0px;outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;user-select: auto;max-inline-size: 100%;line-height: 1.6;justify-content: center;"><section style="margin: 0px;padding: 0px;outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;user-select: auto;max-inline-size: 100%;line-height: 1.6;justify-content: center;"><section data-id="3074" style="margin: 0px;padding: 0px;outline: 0px;max-width: 100%;box-sizing: border-box;overflow-wrap: break-word;color: rgb(0, 0, 0);font-family: 微软雅黑;font-variant-numeric: normal;font-variant-east-asian: normal;font-size: 14px;text-align: left;"><section style="margin: 10px 0px;padding: 0px;outline: 0px;max-width: 100%;box-sizing: border-box;overflow-wrap: break-word;"><section style="margin: 0px;padding: 0px;outline: 0px;max-width: 100%;box-sizing: border-box;overflow-wrap: break-word;align-items: center;display: flex;justify-content: center;"><section data-width="100%" style="margin: 0px;padding: 0px;outline: 0px;max-width: 100%;box-sizing: border-box;overflow-wrap: break-word;border-bottom: 1px solid rgb(88, 88, 88);border-top: 3px solid rgb(88, 88, 88);height: 6px;width: 315.047px;"><br style="margin: 0px;padding: 0px;outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"></section><section data-width="100%" style="margin: 0px;padding: 0px;outline: 0px;max-width: 100%;box-sizing: border-box;overflow-wrap: break-word;border-bottom: 1px solid rgb(88, 88, 88);border-top: 3px solid rgb(88, 88, 88);height: 6px;width: 315.047px;"><br style="margin: 0px;padding: 0px;outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"></section><section data-width="100%" style="margin: 0px;padding: 0px;outline: 0px;max-width: 100%;box-sizing: border-box;overflow-wrap: break-word;border-bottom: 1px solid rgb(88, 88, 88);border-top: 3px solid rgb(88, 88, 88);height: 6px;width: 315.047px;"><br style="margin: 0px;padding: 0px;outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"></section><section data-width="100%" style="margin: 0px;padding: 0px;outline: 0px;max-width: 100%;box-sizing: border-box;overflow-wrap: break-word;border-bottom: 1px solid rgb(88, 88, 88);border-top: 3px solid rgb(88, 88, 88);height: 6px;width: 315.047px;"><br style="margin: 0px;padding: 0px;outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"></section></section></section></section></section></section></section><section powered-by="xiumi.us" style="margin: 10px 0px;padding: 0px;outline: 0px;max-width: 100%;text-align: justify;box-sizing: border-box !important;overflow-wrap: break-word !important;"><section style="margin: 0px;padding: 3px;outline: 0px;max-width: 100%;display: inline-block;width: 677px;vertical-align: top;border-style: solid;border-width: 1px;border-radius: 0px;border-color: rgb(0, 136, 111);box-sizing: border-box !important;overflow-wrap: break-word !important;"><section powered-by="xiumi.us" style="margin: 0px;padding: 10px 15px;outline: 0px;max-width: 100%;display: inline-block;width: 669px;vertical-align: top;box-sizing: border-box !important;overflow-wrap: break-word !important;"><section powered-by="xiumi.us" style="margin: 0px;padding: 0px;outline: 0px;max-width: 100%;transform: translate3d(1px, 0px, 0px);box-sizing: border-box !important;overflow-wrap: break-word !important;"><section style="margin: 0px;padding: 0px;outline: 0px;max-width: 100%;line-height: 1.8;text-align: justify;box-sizing: border-box !important;overflow-wrap: break-word !important;"><p style="color: rgb(0, 0, 0);font-family: Microsoft YaHei, Apple Color Emoji, Emoji Symbols Font, Segoe UI Symbol, Arial, sans-serif;font-size: 13px;font-weight: 400;margin: 0px 0px 10px;padding: 0px;outline: 0px;max-width: 100%;clear: both;min-height: 1em;white-space: normal;letter-spacing: 1.8px;text-align: -webkit-left;text-indent: 0em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="margin: 0px;padding: 0px;outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;font-size: 16px;color: rgb(171, 25, 66);"><strong style="margin: 0px;padding: 0px;outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="margin: 0px;padding: 0px;outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;letter-spacing: 1px;">A：如下</span></strong></span></p><section style="color: rgb(34, 34, 34);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;font-size: 17px;font-weight: 400;margin: 0px 0px 10px;padding: 0px;outline: 0px;max-width: 100%;white-space: normal;letter-spacing: 1.8px;text-align: justify;text-indent: 0em;line-height: 1.5em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="margin: 0px;padding: 0px;outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;font-size: 16px;"><span style="margin: 0px;padding: 0px;outline: 0px;max-width: 100%;font-family: Microsoft YaHei, Apple Color Emoji, Emoji Symbols Font, Segoe UI Symbol, Arial, sans-serif;letter-spacing: 1.8px;">♀</span><strong style="margin: 0px;padding: 0px;outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="margin: 0px;padding: 0px;outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;letter-spacing: 1.8px;font-family: Microsoft YaHei, Apple Color Emoji, Emoji Symbols Font, Segoe UI Symbol, Arial, sans-serif;"> <strong style="margin: 0px;padding: 0px;color: rgb(171, 25, 66);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;font-size: 16px;font-style: normal;font-variant-ligatures: normal;font-variant-caps: normal;letter-spacing: 1.8px;orphans: 2;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 2;word-spacing: 0px;-webkit-text-stroke-width: 0px;background-color: rgb(255, 255, 255);text-decoration-thickness: initial;text-decoration-style: initial;text-decoration-color: initial;outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="margin: 0px;padding: 0px;font-size: 16px;color: rgb(171, 25, 66);outline: 0px;max-width: 100%;letter-spacing: 1px;box-sizing: border-box !important;overflow-wrap: break-word !important;">药</span></strong></span></strong></span><span style="margin: 0px;padding: 0px;outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;font-size: 16px;"><strong style="margin: 0px;padding: 0px;outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="margin: 0px;padding: 0px;outline: 0px;max-width: 100%;color: rgb(102, 102, 102);font-family: Helvetica Neue, PingFang SC, STHeiti, 微软雅黑, Microsoft YaHei, Helvetica, Arial, sans-serif;font-size: 15px;font-style: normal;font-variant-ligatures: normal;font-variant-caps: normal;font-weight: 400;letter-spacing: 1.8px;orphans: 2;text-align: justify;text-indent: 0px;text-transform: none;widows: 2;word-spacing: 0px;-webkit-text-stroke-width: 0px;background-color: rgb(255, 255, 255);text-decoration-thickness: initial;text-decoration-style: initial;text-decoration-color: initial;float: none;box-sizing: border-box !important;overflow-wrap: break-word !important;">物最重要的两个特征为：安全性和有效性。其中安全性是IND申报中监管机构最重视的评价指标之一，需要对生产工艺的存在潜在安全性的物质进行控制，这些影响药物安全性的物质可分为：工艺相关杂质、产品相关杂志、污染物等。</span></strong></span></section><section style="margin: 0px 0px 10px;padding: 0px;outline: 0px;max-width: 100%;white-space: normal;letter-spacing: 1.8px;text-align: justify;text-indent: 0em;line-height: 1.5em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="margin: 0px;padding: 0px;outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="margin: 0px;padding: 0px;outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="margin: 0px;padding: 0px;outline: 0px;max-width: 100%;letter-spacing: 1.8px;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="margin: 0px;padding: 0px;outline: 0px;max-width: 100%;font-style: normal;font-variant-ligatures: normal;font-variant-caps: normal;letter-spacing: 1.8px;orphans: 2;text-align: justify;text-indent: 0px;text-transform: none;widows: 2;word-spacing: 0px;-webkit-text-stroke-width: 0px;background-color: rgb(255, 255, 255);text-decoration-thickness: initial;text-decoration-style: initial;text-decoration-color: initial;float: none;box-sizing: border-box !important;overflow-wrap: break-word !important;display: inline !important;"><span style="color: rgb(34, 34, 34);font-family: Microsoft YaHei, Apple Color Emoji, Emoji Symbols Font, Segoe UI Symbol, Arial, sans-serif;font-size: 16px;font-weight: 400;margin: 0px;padding: 0px;font-style: normal;font-variant-ligatures: normal;font-variant-caps: normal;letter-spacing: 1.8px;orphans: 2;text-align: justify;text-indent: 0px;text-transform: none;widows: 2;word-spacing: 0px;-webkit-text-stroke-width: 0px;background-color: rgb(255, 255, 255);text-decoration-thickness: initial;text-decoration-style: initial;text-decoration-color: initial;outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;">♀</span><span style="margin: 0px;padding: 0px;font-style: normal;font-variant-ligatures: normal;font-variant-caps: normal;letter-spacing: 1.8px;orphans: 2;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 2;word-spacing: 0px;-webkit-text-stroke-width: 0px;background-color: rgb(255, 255, 255);text-decoration-thickness: initial;text-decoration-style: initial;text-decoration-color: initial;outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="color: rgb(34, 34, 34);font-family: Microsoft YaHei, Apple Color Emoji, Emoji Symbols Font, Segoe UI Symbol, Arial, sans-serif;font-size: 16px;font-weight: bold;margin: 0px;padding: 0px;outline: 0px;max-width: 100%;letter-spacing: 1.8px;box-sizing: border-box !important;overflow-wrap: break-word !important;"> <strong style="margin: 0px;padding: 0px;color: rgb(51, 51, 51);font-family: mp-quote, -apple-system-font, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;font-size: 16px;font-style: normal;font-variant-ligatures: normal;font-variant-caps: normal;letter-spacing: 1.8px;orphans: 2;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 2;word-spacing: 0px;-webkit-text-stroke-width: 0px;background-color: rgb(255, 255, 255);text-decoration-thickness: initial;text-decoration-style: initial;text-decoration-color: initial;outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="margin: 0px;padding: 0px;outline: 0px;max-width: 100%;letter-spacing: 1.8px;font-family: Microsoft YaHei, Apple Color Emoji, Emoji Symbols Font, Segoe UI Symbol, Arial, sans-serif;box-sizing: border-box !important;overflow-wrap: break-word !important;"><strong style="margin: 0px;padding: 0px;color: rgb(171, 25, 66);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;font-size: 16px;font-style: normal;font-variant-ligatures: normal;font-variant-caps: normal;letter-spacing: 1.8px;orphans: 2;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 2;word-spacing: 0px;-webkit-text-stroke-width: 0px;background-color: rgb(255, 255, 255);text-decoration-thickness: initial;text-decoration-style: initial;text-decoration-color: initial;outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="margin: 0px;padding: 0px;font-family: Microsoft YaHei, Apple Color Emoji, Emoji Symbols Font, Segoe UI Symbol, Arial, sans-serif;font-size: 16px;color: rgb(171, 25, 66);outline: 0px;max-width: 100%;letter-spacing: 1px;box-sizing: border-box !important;overflow-wrap: break-word !important;">工</span></strong></span></strong></span></span></span></span></span></span><span style="margin: 0px;padding: 0px;outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="margin: 0px;padding: 0px;outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="margin: 0px;padding: 0px;outline: 0px;max-width: 100%;letter-spacing: 1.8px;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="margin: 0px;padding: 0px;outline: 0px;max-width: 100%;font-style: normal;font-variant-ligatures: normal;font-variant-caps: normal;letter-spacing: 1.8px;orphans: 2;text-align: justify;text-indent: 0px;text-transform: none;widows: 2;word-spacing: 0px;-webkit-text-stroke-width: 0px;background-color: rgb(255, 255, 255);text-decoration-thickness: initial;text-decoration-style: initial;text-decoration-color: initial;float: none;box-sizing: border-box !important;overflow-wrap: break-word !important;display: inline !important;"><span style="margin: 0px;padding: 0px;font-style: normal;font-variant-ligatures: normal;font-variant-caps: normal;letter-spacing: 1.8px;orphans: 2;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 2;word-spacing: 0px;-webkit-text-stroke-width: 0px;background-color: rgb(255, 255, 255);text-decoration-thickness: initial;text-decoration-style: initial;text-decoration-color: initial;outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="margin: 0px;padding: 0px;outline: 0px;max-width: 100%;letter-spacing: 1.8px;box-sizing: border-box !important;overflow-wrap: break-word !important;font-size: 15px;"><span style="color:#666666;font-family:Helvetica Neue, PingFang SC, STHeiti, 微软雅黑, Microsoft YaHei, Helvetica, Arial, sans-serif;">艺相关杂志是指来源于生产工艺的对药物安全性和有效性产物影响的物质。又分为具有生物学活性杂质和非生物学活性杂质，<span style="color: rgb(102, 102, 102);font-family: Helvetica Neue, PingFang SC, STHeiti, 微软雅黑, Microsoft YaHei, Helvetica, Arial, sans-serif;font-size: 15px;font-style: normal;font-variant-ligatures: normal;font-variant-caps: normal;font-weight: 400;letter-spacing: 1.8px;orphans: 2;text-align: justify;text-indent: 0px;text-transform: none;widows: 2;word-spacing: 0px;-webkit-text-stroke-width: 0px;background-color: rgb(255, 255, 255);text-decoration-thickness: initial;text-decoration-style: initial;text-decoration-color: initial;display: inline !important;float: none;">生物学活性杂质包含HCP、DNA、Protein A等，非生物学活性杂质包含消泡剂、DMSO等。</span></span></span></span></span></span></span></span></section><section style="margin: 0px 0px 10px;padding: 0px;outline: 0px;max-width: 100%;white-space: normal;letter-spacing: 1.8px;text-align: justify;text-indent: 0em;line-height: 1.5em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="float: none;font-style: normal;font-variant-ligatures: normal;font-variant-caps: normal;orphans: 2;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 2;word-spacing: 0px;-webkit-text-stroke-width: 0px;background-color: rgb(255, 255, 255);text-decoration-thickness: initial;text-decoration-style: initial;text-decoration-color: initial;margin: 0px;padding: 0px;outline: 0px;max-width: 100%;letter-spacing: 1.8px;font-size: 15px;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="color:#666666;font-family:Helvetica Neue, PingFang SC, STHeiti, 微软雅黑, Microsoft YaHei, Helvetica, Arial, sans-serif;"><span style="margin: 0px;padding: 0px;font-style: normal;font-variant-ligatures: normal;font-variant-caps: normal;font-weight: 400;letter-spacing: 1.8px;orphans: 2;text-align: justify;text-indent: 0px;text-transform: none;widows: 2;word-spacing: 0px;-webkit-text-stroke-width: 0px;background-color: rgb(255, 255, 255);text-decoration-thickness: initial;text-decoration-style: initial;text-decoration-color: initial;color: rgb(34, 34, 34);font-family: Microsoft YaHei, Apple Color Emoji, Emoji Symbols Font, Segoe UI Symbol, Arial, sans-serif;font-size: 16px;outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;">♀</span><span style="font-style: normal;font-variant-ligatures: normal;font-variant-caps: normal;orphans: 2;text-align: justify;text-indent: 0px;text-transform: none;widows: 2;word-spacing: 0px;-webkit-text-stroke-width: 0px;background-color: rgb(255, 255, 255);text-decoration-thickness: initial;text-decoration-style: initial;text-decoration-color: initial;margin: 0px;padding: 0px;color: rgb(34, 34, 34);font-family: Microsoft YaHei, Apple Color Emoji, Emoji Symbols Font, Segoe UI Symbol, Arial, sans-serif;font-size: 16px;font-weight: bold;outline: 0px;max-width: 100%;letter-spacing: 1.8px;box-sizing: border-box !important;overflow-wrap: break-word !important;"> <strong style="margin: 0px;padding: 0px;font-size: 16px;font-style: normal;font-variant-ligatures: normal;font-variant-caps: normal;letter-spacing: 1.8px;orphans: 2;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 2;word-spacing: 0px;-webkit-text-stroke-width: 0px;text-decoration-thickness: initial;text-decoration-style: initial;text-decoration-color: initial;color: rgb(51, 51, 51);font-family: mp-quote, -apple-system-font, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;background-color: rgb(255, 255, 255);outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="margin: 0px;padding: 0px;outline: 0px;max-width: 100%;letter-spacing: 1.8px;font-family: Microsoft YaHei, Apple Color Emoji, Emoji Symbols Font, Segoe UI Symbol, Arial, sans-serif;box-sizing: border-box !important;overflow-wrap: break-word !important;"><strong style="margin: 0px;padding: 0px;color: rgb(171, 25, 66);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;font-size: 16px;font-style: normal;font-variant-ligatures: normal;font-variant-caps: normal;letter-spacing: 1.8px;orphans: 2;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 2;word-spacing: 0px;-webkit-text-stroke-width: 0px;background-color: rgb(255, 255, 255);text-decoration-thickness: initial;text-decoration-style: initial;text-decoration-color: initial;outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="margin: 0px;padding: 0px;font-style: normal;font-variant-ligatures: normal;font-variant-caps: normal;orphans: 2;text-align: justify;text-indent: 0px;text-transform: none;widows: 2;word-spacing: 0px;-webkit-text-stroke-width: 0px;background-color: rgb(255, 255, 255);text-decoration-thickness: initial;text-decoration-style: initial;text-decoration-color: initial;font-weight: bold;font-family: Microsoft YaHei, Apple Color Emoji, Emoji Symbols Font, Segoe UI Symbol, Arial, sans-serif;font-size: 16px;color: rgb(171, 25, 66);outline: 0px;max-width: 100%;letter-spacing: 1px;display: inline !important;box-sizing: border-box !important;overflow-wrap: break-word !important;">非</span></strong></span></strong></span></span></span><span style="float: none;font-style: normal;font-variant-ligatures: normal;font-variant-caps: normal;orphans: 2;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 2;word-spacing: 0px;-webkit-text-stroke-width: 0px;background-color: rgb(255, 255, 255);text-decoration-thickness: initial;text-decoration-style: initial;text-decoration-color: initial;margin: 0px;padding: 0px;outline: 0px;max-width: 100%;letter-spacing: 1.8px;font-size: 15px;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="color:#666666;font-family:Helvetica Neue, PingFang SC, STHeiti, 微软雅黑, Microsoft YaHei, Helvetica, Arial, sans-serif;"><span style="color: rgb(102, 102, 102);font-family: Helvetica Neue, PingFang SC, STHeiti, 微软雅黑, Microsoft YaHei, Helvetica, Arial, sans-serif;font-size: 15px;font-style: normal;font-variant-ligatures: normal;font-variant-caps: normal;font-weight: 400;letter-spacing: 1.8px;orphans: 2;text-align: justify;text-indent: 0px;text-transform: none;widows: 2;word-spacing: 0px;-webkit-text-stroke-width: 0px;background-color: rgb(255, 255, 255);text-decoration-thickness: initial;text-decoration-style: initial;text-decoration-color: initial;display: inline !important;float: none;">生物学活性杂质可以采用ISF工具进行评估。</span></span></span></section><p style="color: rgb(62, 62, 62);font-family: -apple-system-font, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;font-size: 13px;font-weight: 400;margin: 0px;padding: 0px;outline: 0px;max-width: 100%;clear: both;min-height: 1em;white-space: normal;letter-spacing: 1.8px;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="margin: 0px;padding: 0px;outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;font-size: 15px;color: rgb(0, 0, 0);text-align: center;font-weight: 700;text-indent: 34px;letter-spacing: 5px;font-family: arial, helvetica, sans-serif;"> </span></p></section></section></section></section></section><section style="color: rgb(34, 34, 34);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;font-size: 17px;font-weight: 400;margin: 0px;padding: 0px;outline: 0px;max-width: 100%;white-space: normal;letter-spacing: 0.544px;user-select: auto;max-inline-size: 100%;line-height: 1.6;justify-content: center;box-sizing: border-box !important;overflow-wrap: break-word !important;"><section style="margin: 0px;padding: 0px;outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;user-select: auto;max-inline-size: 100%;line-height: 1.6;justify-content: center;"><section style="margin: 0px;padding: 0px;outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;user-select: auto;max-inline-size: 100%;line-height: 1.6;justify-content: center;"><section style="margin: 0px;padding: 0px;outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;letter-spacing: 0.544px;user-select: auto;max-inline-size: 100%;line-height: 1.6;justify-content: center;"><section style="margin: 0px;padding: 0px;outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;font-family: Microsoft YaHei, Apple Color Emoji, Emoji Symbols Font, Segoe UI Symbol, Arial, sans-serif;color: rgb(0, 0, 0);user-select: auto;max-inline-size: 100%;line-height: 1.6;justify-content: center;"><section style="margin: 0px;padding: 0px;outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;user-select: auto;max-inline-size: 100%;line-height: 1.6;justify-content: center;"><section style="margin: 0px;padding: 0px;outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;user-select: auto;max-inline-size: 100%;line-height: 1.6;justify-content: center;"><section style="letter-spacing: 0.544px; outline: 0px; user-select: auto; line-height: 1.6; justify-content: center; max-width: 100%; max-inline-size: 100%; box-sizing: border-box !important;"><section style="outline: 0px; user-select: auto; line-height: 1.6; justify-content: center; max-width: 100%; max-inline-size: 100%; box-sizing: border-box !important;"><section style="outline: 0px; user-select: auto; line-height: 1.6; justify-content: center; max-width: 100%; max-inline-size: 100%; box-sizing: border-box !important;"><p style="margin-top: 15px; margin-bottom: 5px; outline: 0px; max-width: 100%; clear: both; min-height: 1em; text-indent: 0em; text-align: justify; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; text-align: left; color: rgb(0, 122, 170); font-size: 16px; box-sizing: border-box !important;"><strong style="outline: 0px; max-width: 100%; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; letter-spacing: 1px; box-sizing: border-box !important;">♂</span></strong></span><span style="outline: 0px; max-width: 100%; text-align: left; color: rgb(0, 122, 170); box-sizing: border-box !important;"><strong style="outline: 0px; max-width: 100%; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; letter-spacing: 0.5px; font-size: 16px; box-sizing: border-box !important;">Q</span></strong></span><strong style="outline: 0px; max-width: 100%; text-align: left; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; font-family: Arial, sans-serif; font-size: 15px; box-sizing: border-box !important;">404</span></strong><span style="outline: 0px; max-width: 100%; text-align: left; color: rgb(0, 122, 170); font-size: 16px; box-sizing: border-box !important;"><strong style="outline: 0px; max-width: 100%; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; letter-spacing: 0.5px; box-sizing: border-box !important;"> </span></strong></span><span style="outline: 0px; max-width: 100%; text-align: left; color: rgb(0, 122, 170); font-size: 16px; box-sizing: border-box !important;"><strong style="outline: 0px; max-width: 100%; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; letter-spacing: 0.5px; box-sizing: border-box !important;">ISF评估过程是怎么样的？</span></strong></span></p><section data-id="3074" style="outline: 0px; max-width: 100%; box-sizing: border-box; font-variant-numeric: normal; font-variant-east-asian: normal; font-size: 14px; font-family: 微软雅黑; text-align: left;"><section style="margin-top: 10px; margin-bottom: 10px; outline: 0px; max-width: 100%; box-sizing: border-box;"><section style="outline: 0px; max-width: 100%; box-sizing: border-box; align-items: center; display: flex; justify-content: center;"><section data-width="100%" style="outline: 0px; max-width: 100%; box-sizing: border-box; border-bottom: 1px solid rgb(88, 88, 88); border-top: 3px solid rgb(88, 88, 88); height: 6px; width: 315.047px;"><br style="outline: 0px; max-width: 100%; box-sizing: border-box !important;"></section><section data-width="100%" style="outline: 0px; max-width: 100%; box-sizing: border-box; border-bottom: 1px solid rgb(88, 88, 88); border-top: 3px solid rgb(88, 88, 88); height: 6px; width: 315.047px;"><br style="outline: 0px; max-width: 100%; box-sizing: border-box !important;"></section><section data-width="100%" style="outline: 0px; max-width: 100%; box-sizing: border-box; border-bottom: 1px solid rgb(88, 88, 88); border-top: 3px solid rgb(88, 88, 88); height: 6px; width: 315.047px;"><br style="outline: 0px; max-width: 100%; box-sizing: border-box !important;"></section><section data-width="100%" style="outline: 0px; max-width: 100%; box-sizing: border-box; border-bottom: 1px solid rgb(88, 88, 88); border-top: 3px solid rgb(88, 88, 88); height: 6px; width: 315.047px;"><br style="outline: 0px; max-width: 100%; box-sizing: border-box !important;"></section></section></section></section></section></section></section><p style="margin-top: 15px; margin-bottom: 5px; outline: 0px; max-width: 100%; clear: both; min-height: 1em; text-indent: 0em; text-align: justify; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; text-align: left; color: rgb(0, 122, 170); font-size: 16px; box-sizing: border-box !important;"><strong style="outline: 0px; max-width: 100%; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; letter-spacing: 1px; box-sizing: border-box !important;"></span></strong></span></p><section powered-by="xiumi.us" style="margin-top: 10px; margin-bottom: 10px; color: rgb(34, 34, 34); font-family: -apple-system, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; letter-spacing: 0.544px; outline: 0px; max-width: 100%; text-align: justify; box-sizing: border-box !important;"><section style="padding: 3px; outline: 0px; max-width: 100%; display: inline-block; width: 677px; vertical-align: top; border-style: solid; border-width: 1px; border-radius: 0px; border-color: rgb(0, 136, 111); box-sizing: border-box !important;"><section powered-by="xiumi.us" style="padding: 10px 15px; outline: 0px; max-width: 100%; display: inline-block; width: 669px; vertical-align: top; box-sizing: border-box !important;"><section powered-by="xiumi.us" style="outline: 0px; max-width: 100%; transform: translate3d(1px, 0px, 0px); box-sizing: border-box !important;"><section style="outline: 0px; max-width: 100%; line-height: 1.8; box-sizing: border-box !important;"><p style="margin-bottom: 10px; outline: 0px; max-width: 100%; clear: both; min-height: 1em; font-family: "Microsoft YaHei", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; font-size: 13px; letter-spacing: 1.8px; color: rgb(0, 0, 0); text-align: -webkit-left; text-indent: 0em; box-sizing: border-box !important;"><strong style="outline: 0px; max-width: 100%; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; color: rgb(171, 25, 66); font-size: 16px; letter-spacing: 1px; box-sizing: border-box !important;">A：如下</span></strong></p><section style="margin-bottom: 10px; outline: 0px; max-width: 100%; font-family: "Microsoft YaHei", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; font-size: 13px; letter-spacing: 1.8px; line-height: 2em; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; font-size: 16px; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; text-align: center; font-family: Arial, sans-serif; box-sizing: border-box !important;">♀</span><span style="outline: 0px; max-width: 100%; color: rgb(62, 62, 62); letter-spacing: 1.8px; font-family: -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; box-sizing: border-box !important;"> </span></span><span style="outline: 0px; max-width: 100%; color: rgb(102, 102, 102); font-family: "Helvetica Neue", "PingFang SC", STHeiti, 微软雅黑, "Microsoft YaHei", Helvetica, Arial, sans-serif; font-size: 15px; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; box-sizing: border-box !important;"><span style="color: rgb(51, 51, 51); font-family: mp-quote, -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; letter-spacing: 1.8px; outline: 0px; max-width: 100%; box-sizing: border-box !important;"><span style="color: rgb(102, 102, 102); font-family: "Helvetica Neue", "PingFang SC", STHeiti, 微软雅黑, "Microsoft YaHei", Helvetica, Arial, sans-serif;"><span style="color: rgb(34, 34, 34); font-family: "Microsoft YaHei", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; font-size: 16px; font-weight: bold; outline: 0px; max-width: 100%; letter-spacing: 1.8px; box-sizing: border-box !important;"><strong style="letter-spacing: 1.8px; color: rgb(51, 51, 51); font-family: mp-quote, -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; outline: 0px; max-width: 100%; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; font-family: "Microsoft YaHei", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; box-sizing: border-box !important;"><strong style="color: rgb(171, 25, 66); font-family: -apple-system, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; letter-spacing: 1.8px; outline: 0px; max-width: 100%; box-sizing: border-box !important;"><span style="font-family: "Microsoft YaHei", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; outline: 0px; max-width: 100%; letter-spacing: 1px; box-sizing: border-box !important;">ISF</span></strong></span></strong></span></span></span><span style="color: rgb(51, 51, 51); font-family: mp-quote, -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; letter-spacing: 1.8px; outline: 0px; max-width: 100%; box-sizing: border-box !important;"><span style="color: rgb(102, 102, 102); font-family: "Helvetica Neue", "PingFang SC", STHeiti, 微软雅黑, "Microsoft YaHei", Helvetica, Arial, sans-serif;"><span style="letter-spacing: 1.8px;">的计算公式为：ISF=LD50/每剂量中的杂质含量。LD50为半数致死量，<span style="letter-spacing: 1.8px;">各物质的LD50可以相关文献或者网站中查到。<span style="letter-spacing: 1.8px;">每</span><span style="letter-spacing: 1.8px;">剂量中的杂质含量为生产过程中杂质最大量来计算。</span></span></span></span></span></span></span><span style="outline: 0px; max-width: 100%; color: rgb(102, 102, 102); font-family: "Helvetica Neue", "PingFang SC", STHeiti, 微软雅黑, "Microsoft YaHei", Helvetica, Arial, sans-serif; font-size: 15px; letter-spacing: 1.8px; box-sizing: border-box !important;"></span></section><section style="margin-bottom: 10px; outline: 0px; max-width: 100%; font-family: "Microsoft YaHei", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; font-size: 13px; letter-spacing: 1.8px; line-height: 2em; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; color: rgb(102, 102, 102); font-family: "Helvetica Neue", "PingFang SC", STHeiti, 微软雅黑, "Microsoft YaHei", Helvetica, Arial, sans-serif; font-size: 15px; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; box-sizing: border-box !important;"><span style="color: rgb(51, 51, 51); font-family: mp-quote, -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; letter-spacing: 1.8px; outline: 0px; max-width: 100%; box-sizing: border-box !important;"><span style="color: rgb(102, 102, 102); font-family: "Helvetica Neue", "PingFang SC", STHeiti, 微软雅黑, "Microsoft YaHei", Helvetica, Arial, sans-serif;"><span style="letter-spacing: 1.8px;"><span style="letter-spacing: 1.8px;"><span style="color: rgb(34, 34, 34); font-family: "Microsoft YaHei", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; letter-spacing: 1.8px; outline: 0px; max-width: 100%; font-size: 16px; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; text-align: center; font-family: Arial, sans-serif; box-sizing: border-box !important;">♀</span><span style="outline: 0px; max-width: 100%; color: rgb(62, 62, 62); letter-spacing: 1.8px; font-family: -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; box-sizing: border-box !important;"> </span></span><span style="letter-spacing: 1.8px; outline: 0px; max-width: 100%; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; box-sizing: border-box !important;"><span style="color: rgb(51, 51, 51); font-family: mp-quote, -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; letter-spacing: 1.8px; outline: 0px; max-width: 100%; box-sizing: border-box !important;"><span style="color: rgb(102, 102, 102); font-family: "Helvetica Neue", "PingFang SC", STHeiti, 微软雅黑, "Microsoft YaHei", Helvetica, Arial, sans-serif;"><span style="color: rgb(34, 34, 34); font-family: "Microsoft YaHei", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; font-size: 16px; font-weight: bold; outline: 0px; max-width: 100%; letter-spacing: 1.8px; box-sizing: border-box !important;"><strong style="letter-spacing: 1.8px; color: rgb(51, 51, 51); font-family: mp-quote, -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; outline: 0px; max-width: 100%; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; font-family: "Microsoft YaHei", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; box-sizing: border-box !important;"><strong style="color: rgb(171, 25, 66); font-family: -apple-system, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; letter-spacing: 1.8px; outline: 0px; max-width: 100%; box-sizing: border-box !important;"><span style="font-family: "Microsoft YaHei", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; outline: 0px; max-width: 100%; letter-spacing: 1px; box-sizing: border-box !important;">前</span></strong></span></strong></span></span></span><span style="color: rgb(51, 51, 51); font-family: mp-quote, -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; letter-spacing: 1.8px; outline: 0px; max-width: 100%; box-sizing: border-box !important;"><span style="color: rgb(102, 102, 102); font-family: "Helvetica Neue", "PingFang SC", STHeiti, 微软雅黑, "Microsoft YaHei", Helvetica, Arial, sans-serif;"><span style="letter-spacing: 1.8px;"><span style="letter-spacing: 1.8px;">提：基于下游对杂质无任何去除能力，此时杂质的含量最高，相当于开展worst-case评估。</span></span></span></span></span></span></span></span></span></span></span></span></section><section style="margin-bottom: 10px; outline: 0px; max-width: 100%; font-family: "Microsoft YaHei", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; font-size: 13px; letter-spacing: 1.8px; line-height: 2em; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; color: rgb(102, 102, 102); font-family: "Helvetica Neue", "PingFang SC", STHeiti, 微软雅黑, "Microsoft YaHei", Helvetica, Arial, sans-serif; font-size: 15px; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; box-sizing: border-box !important;"><span style="color: rgb(51, 51, 51); font-family: mp-quote, -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; letter-spacing: 1.8px; outline: 0px; max-width: 100%; box-sizing: border-box !important;"><span style="color: rgb(102, 102, 102); font-family: "Helvetica Neue", "PingFang SC", STHeiti, 微软雅黑, "Microsoft YaHei", Helvetica, Arial, sans-serif;"><span style="letter-spacing: 1.8px;"><span style="letter-spacing: 1.8px;"><span style="letter-spacing: 1.8px; outline: 0px; max-width: 100%; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; box-sizing: border-box !important;"><span style="color: rgb(51, 51, 51); font-family: mp-quote, -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; letter-spacing: 1.8px; outline: 0px; max-width: 100%; box-sizing: border-box !important;"><span style="color: rgb(102, 102, 102); font-family: "Helvetica Neue", "PingFang SC", STHeiti, 微软雅黑, "Microsoft YaHei", Helvetica, Arial, sans-serif;"><span style="letter-spacing: 1.8px;"><span style="letter-spacing: 1.8px;"><span style="letter-spacing: 1.8px; color: rgb(34, 34, 34); font-family: "Microsoft YaHei", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; outline: 0px; max-width: 100%; font-size: 16px; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; text-align: center; font-family: Arial, sans-serif; box-sizing: border-box !important;">♀</span><span style="outline: 0px; max-width: 100%; color: rgb(62, 62, 62); letter-spacing: 1.8px; font-family: -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; box-sizing: border-box !important;"> </span></span><span style="letter-spacing: 1.8px; outline: 0px; max-width: 100%; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; box-sizing: border-box !important;"><span style="color: rgb(51, 51, 51); font-family: mp-quote, -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; letter-spacing: 1.8px; outline: 0px; max-width: 100%; box-sizing: border-box !important;"><span style="color: rgb(102, 102, 102); font-family: "Helvetica Neue", "PingFang SC", STHeiti, 微软雅黑, "Microsoft YaHei", Helvetica, Arial, sans-serif;"><span style="color: rgb(34, 34, 34); font-family: "Microsoft YaHei", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; font-size: 16px; font-weight: bold; outline: 0px; max-width: 100%; letter-spacing: 1.8px; box-sizing: border-box !important;"><strong style="letter-spacing: 1.8px; color: rgb(51, 51, 51); font-family: mp-quote, -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; outline: 0px; max-width: 100%; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; font-family: "Microsoft YaHei", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; box-sizing: border-box !important;"><strong style="color: rgb(171, 25, 66); font-family: -apple-system, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; letter-spacing: 1.8px; outline: 0px; max-width: 100%; box-sizing: border-box !important;"><span style="font-family: "Microsoft YaHei", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; outline: 0px; max-width: 100%; letter-spacing: 1px; box-sizing: border-box !important;">步</span></strong></span></strong></span></span></span><span style="color: rgb(51, 51, 51); font-family: mp-quote, -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; letter-spacing: 1.8px; outline: 0px; max-width: 100%; box-sizing: border-box !important;"><span style="color: rgb(102, 102, 102); font-family: "Helvetica Neue", "PingFang SC", STHeiti, 微软雅黑, "Microsoft YaHei", Helvetica, Arial, sans-serif;"><span style="letter-spacing: 1.8px;"><span style="letter-spacing: 1.8px;">骤：根据公式（<span style="letter-spacing: 1.8px;">ISF=LD</span><span style="letter-spacing: 1.8px;">50</span><span style="letter-spacing: 1.8px;">/</span><span style="letter-spacing: 1.8px;">每</span><span style="letter-spacing: 1.8px;">剂量中的杂质含量</span>）进行计算，1. 当IFS大于1000时评估为安全；2. 当ISF小于1000时，需要在后续纯化步骤中检测相关杂质含量，检测后如<span style="letter-spacing: 1.8px;">IFS大于1000时评估为安全</span>；3. <span style="letter-spacing: 1.8px;">检测后</span><span style="letter-spacing: 1.8px;">如</span><span style="letter-spacing: 1.8px;">IFS小于1000时需要开展Spiking研究。</span><div style="display: inline;"><p style="text-align: center;"></p></div></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></section></section></section></section></section></section><section style="outline: 0px; user-select: auto; line-height: 1.6; justify-content: center; visibility: visible; max-width: 100%; max-inline-size: 100%; box-sizing: border-box !important;"><section style="outline: 0px; letter-spacing: 0.544px; user-select: auto; line-height: 1.6; justify-content: center; max-width: 100%; max-inline-size: 100%; box-sizing: border-box !important;"><section style="outline: 0px; user-select: auto; line-height: 1.6; justify-content: center; max-width: 100%; max-inline-size: 100%; box-sizing: border-box !important;"><section style="outline: 0px; user-select: auto; line-height: 1.6; justify-content: center; max-width: 100%; max-inline-size: 100%; box-sizing: border-box !important;"><section style="outline: 0px; color: rgb(34, 34, 34); font-family: -apple-system, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; letter-spacing: 0.544px; user-select: auto; line-height: 1.6; justify-content: center; max-width: 100%; max-inline-size: 100%; box-sizing: border-box !important;"><section style="outline: 0px; user-select: auto; line-height: 1.6; justify-content: center; max-width: 100%; max-inline-size: 100%; box-sizing: border-box !important;"><section style="outline: 0px; user-select: auto; line-height: 1.6; justify-content: center; max-width: 100%; max-inline-size: 100%; box-sizing: border-box !important;"><p style="margin-top: 15px; margin-bottom: 5px; outline: 0px; max-width: 100%; clear: both; min-height: 1em; text-indent: 0em; text-align: justify; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; letter-spacing: 0.544px; color: rgb(0, 122, 170); font-family: "Microsoft YaHei", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; font-size: 16px; box-sizing: border-box !important;"><strong style="outline: 0px; max-width: 100%; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; letter-spacing: 1px; box-sizing: border-box !important;">♂</span></strong></span><span style="outline: 0px; max-width: 100%; letter-spacing: 0.544px; text-align: left; box-sizing: border-box !important;"><strong style="outline: 0px; max-width: 100%; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; color: rgb(0, 122, 170); font-family: "Microsoft YaHei", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; letter-spacing: 0.5px; font-size: 16px; box-sizing: border-box !important;">Q</span><span style="outline: 0px; max-width: 100%; font-size: 15px; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; color: rgb(0, 0, 0); font-family: Arial, sans-serif; box-sizing: border-box !important;">405</span></span></strong></span><strong style="outline: 0px; max-width: 100%; color: rgb(0, 122, 170); font-family: "Microsoft YaHei", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; text-align: left; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; letter-spacing: 0.5px; font-size: 16px; box-sizing: border-box !important;"> </span><span style="outline: 0px; max-width: 100%; font-size: 16px; letter-spacing: 1.8px; box-sizing: border-box !important;"> <strong style="outline: 0px; max-width: 100%; letter-spacing: 0.544px; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; letter-spacing: 0.5px; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; box-sizing: border-box !important;">为何ISF评估判断安全的标准是大于1000？</span></span></strong><br data-filtered="filtered" style="outline: 0px; max-width: 100%; box-sizing: border-box !important;"></span></strong><span style="outline: 0px; max-width: 100%; font-family: arial; letter-spacing: 0.544px; box-sizing: border-box !important;"></span></p><section data-id="3074" style="outline: 0px; max-width: 100%; box-sizing: border-box; letter-spacing: 0.544px; color: rgb(0, 0, 0); font-family: 微软雅黑; font-variant-numeric: normal; font-variant-east-asian: normal; font-size: 14px; text-align: left;"><section style="margin-top: 10px; margin-bottom: 10px; outline: 0px; max-width: 100%; box-sizing: border-box;"><section style="outline: 0px; max-width: 100%; box-sizing: border-box; align-items: center; display: flex; justify-content: center;"><section data-width="100%" style="outline: 0px; max-width: 100%; box-sizing: border-box; border-bottom: 1px solid rgb(88, 88, 88); border-top: 3px solid rgb(88, 88, 88); height: 6px; width: 315.047px;"><br data-filtered="filtered" style="outline: 0px; max-width: 100%; box-sizing: border-box !important;"></section><section data-width="100%" style="outline: 0px; max-width: 100%; box-sizing: border-box; border-bottom: 1px solid rgb(88, 88, 88); border-top: 3px solid rgb(88, 88, 88); height: 6px; width: 315.047px;"><br data-filtered="filtered" style="outline: 0px; max-width: 100%; box-sizing: border-box !important;"></section><section data-width="100%" style="outline: 0px; max-width: 100%; box-sizing: border-box; border-bottom: 1px solid rgb(88, 88, 88); border-top: 3px solid rgb(88, 88, 88); height: 6px; width: 315.047px;"><br data-filtered="filtered" style="outline: 0px; max-width: 100%; box-sizing: border-box !important;"></section><section data-width="100%" style="outline: 0px; max-width: 100%; box-sizing: border-box; border-bottom: 1px solid rgb(88, 88, 88); border-top: 3px solid rgb(88, 88, 88); height: 6px; width: 315.047px;"><br data-filtered="filtered" style="outline: 0px; max-width: 100%; box-sizing: border-box !important;"></section></section></section></section></section></section></section><section powered-by="xiumi.us" style="margin-top: 10px; margin-bottom: 10px; outline: 0px; max-width: 100%; color: rgb(34, 34, 34); font-family: -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; letter-spacing: 0.544px; box-sizing: border-box !important;"><section style="padding: 3px; outline: 0px; max-width: 100%; display: inline-block; width: 677px; vertical-align: top; border-style: solid; border-width: 1px; border-radius: 0px; border-color: rgb(0, 136, 111); box-sizing: border-box !important;"><section powered-by="xiumi.us" style="padding: 10px 15px; outline: 0px; max-width: 100%; display: inline-block; width: 669px; vertical-align: top; box-sizing: border-box !important;"><p style="margin-bottom: 10px; outline: 0px; max-width: 100%; clear: both; min-height: 1em; color: rgb(0, 0, 0); font-size: 15px; letter-spacing: 0.8px; font-family: "Microsoft YaHei", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; text-align: justify; text-indent: 0em; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; font-size: 16px; color: rgb(171, 25, 66); box-sizing: border-box !important;"><strong style="outline: 0px; max-width: 100%; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; letter-spacing: 1px; box-sizing: border-box !important;">A</span></strong><strong style="outline: 0px; max-width: 100%; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; letter-spacing: 1px; box-sizing: border-box !important;">：如下</span></strong></span></p><section style="margin-bottom: 10px; outline: 0px; max-width: 100%; font-size: 13px; text-align: justify; line-height: 2em; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; color: rgb(62, 62, 62); letter-spacing: 0.8px; font-size: 15px; font-family: Arial, sans-serif; text-align: center; box-sizing: border-box !important;">♀</span><span style="outline: 0px; max-width: 100%; color: rgb(62, 62, 62); letter-spacing: 0.8px; font-family: Arial, sans-serif; text-align: center; font-size: 16px; box-sizing: border-box !important;"> </span><span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; color: rgb(102, 102, 102); font-family: "Helvetica Neue", "PingFang SC", STHeiti, 微软雅黑, "Microsoft YaHei", Helvetica, Arial, sans-serif; font-size: 15px; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; color: rgb(51, 51, 51); font-family: mp-quote, -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; letter-spacing: 1.8px; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; color: rgb(102, 102, 102); font-family: "Helvetica Neue", "PingFang SC", STHeiti, 微软雅黑, "Microsoft YaHei", Helvetica, Arial, sans-serif; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; color: rgb(34, 34, 34); font-family: "Microsoft YaHei", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; font-size: 16px; font-weight: bold; letter-spacing: 1.8px; box-sizing: border-box !important;"><strong style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; color: rgb(51, 51, 51); font-family: mp-quote, -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; font-family: "Microsoft YaHei", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; box-sizing: border-box !important;"><strong style="outline: 0px; max-width: 100%; color: rgb(171, 25, 66); font-family: -apple-system, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; letter-spacing: 1.8px; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; font-family: "Microsoft YaHei", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; letter-spacing: 1px; box-sizing: border-box !important;">ISF</span></strong></span></strong></span></span></span><span style="outline: 0px; max-width: 100%; color: rgb(51, 51, 51); font-family: mp-quote, -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; letter-spacing: 1.8px; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; color: rgb(102, 102, 102); font-family: "Helvetica Neue", "PingFang SC", STHeiti, 微软雅黑, "Microsoft YaHei", Helvetica, Arial, sans-serif; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; box-sizing: border-box !important;">的计算公式为：ISF=LD50/每剂量中的杂质含量。</span></span></span></span></span></span></section><section style="margin-bottom: 10px; outline: 0px; max-width: 100%; font-size: 13px; text-align: justify; line-height: 2em; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; color: rgb(102, 102, 102); font-family: "Helvetica Neue", "PingFang SC", STHeiti, 微软雅黑, "Microsoft YaHei", Helvetica, Arial, sans-serif; font-size: 15px; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; color: rgb(51, 51, 51); font-family: mp-quote, -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; letter-spacing: 1.8px; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; color: rgb(102, 102, 102); font-family: "Helvetica Neue", "PingFang SC", STHeiti, 微软雅黑, "Microsoft YaHei", Helvetica, Arial, sans-serif; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; color: rgb(51, 51, 51); font-family: mp-quote, -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; letter-spacing: 1.8px; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; color: rgb(102, 102, 102); font-family: "Helvetica Neue", "PingFang SC", STHeiti, 微软雅黑, "Microsoft YaHei", Helvetica, Arial, sans-serif; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; color: rgb(34, 34, 34); font-family: "Microsoft YaHei", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; font-size: 16px; font-weight: bold; letter-spacing: 1.8px; box-sizing: border-box !important;"><strong style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; color: rgb(51, 51, 51); font-family: mp-quote, -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; font-family: "Microsoft YaHei", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; box-sizing: border-box !important;"><strong style="outline: 0px; max-width: 100%; color: rgb(171, 25, 66); font-family: -apple-system, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; letter-spacing: 1.8px; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; font-family: "Microsoft YaHei", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; letter-spacing: 1px; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; font-weight: 400; color: rgb(62, 62, 62); letter-spacing: 0.8px; font-size: 15px; font-family: Arial, sans-serif; text-align: center; box-sizing: border-box !important;">♀ </span>毒</span></strong></span></strong></span></span></span><span style="outline: 0px; max-width: 100%; color: rgb(51, 51, 51); font-family: mp-quote, -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; letter-spacing: 1.8px; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; color: rgb(102, 102, 102); font-family: "Helvetica Neue", "PingFang SC", STHeiti, 微软雅黑, "Microsoft YaHei", Helvetica, Arial, sans-serif; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; box-sizing: border-box !important;">性评价指标：有两个毒性评价指标，分别为<span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; box-sizing: border-box !important;">NOAEL (no observed </span><span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; box-sizing: border-box !important;">adverse </span><span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; box-sizing: border-box !important;">effects level)和LD50，其中LD50是从杂质对动物毒性死亡的角度进行评估，而<span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; box-sizing: border-box !important;">NOAE</span><span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; box-sizing: border-box !important;">L未观察到有害作用的剂量水平。在临床试验中对杂质进行评估(ISF)时，理论上采用<span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; box-sizing: border-box !important;">NOAE</span><span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; box-sizing: border-box !important;">L进行计算更合理。但对于大多数物质<span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; box-sizing: border-box !important;">NOAE</span><span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; box-sizing: border-box !important;">L一般很查到，LD50值却很容易获得，故采用<span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; box-sizing: border-box !important;">LD50</span><span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; box-sizing: border-box !important;">值进行ISF计算比较方便。</span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></section><section style="margin-bottom: 10px; outline: 0px; max-width: 100%; font-size: 13px; text-align: justify; line-height: 2em; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; color: rgb(102, 102, 102); font-family: "Helvetica Neue", "PingFang SC", STHeiti, 微软雅黑, "Microsoft YaHei", Helvetica, Arial, sans-serif; font-size: 15px; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; color: rgb(51, 51, 51); font-family: mp-quote, -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; letter-spacing: 1.8px; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; color: rgb(102, 102, 102); font-family: "Helvetica Neue", "PingFang SC", STHeiti, 微软雅黑, "Microsoft YaHei", Helvetica, Arial, sans-serif; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; color: rgb(51, 51, 51); font-family: mp-quote, -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; letter-spacing: 1.8px; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; color: rgb(102, 102, 102); font-family: "Helvetica Neue", "PingFang SC", STHeiti, 微软雅黑, "Microsoft YaHei", Helvetica, Arial, sans-serif; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; color: rgb(51, 51, 51); font-family: mp-quote, -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; color: rgb(102, 102, 102); font-family: "Helvetica Neue", "PingFang SC", STHeiti, 微软雅黑, "Microsoft YaHei", Helvetica, Arial, sans-serif; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; color: rgb(34, 34, 34); font-family: "Microsoft YaHei", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; font-size: 16px; font-weight: bold; letter-spacing: 1.8px; box-sizing: border-box !important;"><strong style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; color: rgb(51, 51, 51); font-family: mp-quote, -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; font-family: "Microsoft YaHei", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; box-sizing: border-box !important;"><strong style="outline: 0px; max-width: 100%; color: rgb(171, 25, 66); font-family: -apple-system, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; letter-spacing: 1.8px; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; font-family: "Microsoft YaHei", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; letter-spacing: 1px; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; font-weight: 400; color: rgb(62, 62, 62); letter-spacing: 0.8px; font-size: 15px; font-family: Arial, sans-serif; text-align: center; box-sizing: border-box !important;">♀ </span>标</span></strong></span></strong></span></span></span><span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; color: rgb(51, 51, 51); font-family: mp-quote, -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; color: rgb(102, 102, 102); font-family: "Helvetica Neue", "PingFang SC", STHeiti, 微软雅黑, "Microsoft YaHei", Helvetica, Arial, sans-serif; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; box-sizing: border-box !important;">准：研究显示，通常物质的<span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; box-sizing: border-box !important;">LD50</span>值通常是<span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; box-sizing: border-box !important;">NOA</span><span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; box-sizing: border-box !important;">E</span><span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; box-sizing: border-box !important;">L值的10～100倍，在进行ISF评估时，乘以10倍的安全系数，故判断标准为大于1000。ISF大于1000理论上是不会观察到<span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; box-sizing: border-box !important;">有害</span><span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; box-sizing: border-box !important;">作用，因为在此前提下杂质水平低于<span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; box-sizing: border-box !important;">NOA</span><span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; box-sizing: border-box !important;">E</span><span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; box-sizing: border-box !important;">L。</span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></section></section></section></section></section></section></section><section style="outline: 0px; user-select: auto; line-height: 1.6; justify-content: center; max-width: 100%; max-inline-size: 100%; box-sizing: border-box !important;"><section style="outline: 0px; user-select: auto; line-height: 1.6; justify-content: center; max-width: 100%; max-inline-size: 100%; box-sizing: border-box !important;"><section style="outline: 0px; user-select: auto; line-height: 1.6; justify-content: center; max-width: 100%; max-inline-size: 100%; box-sizing: border-box !important;"><p style="margin-top: 15px; margin-bottom: 5px; outline: 0px; max-width: 100%; clear: both; min-height: 1em; text-indent: 0em; text-align: justify; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; color: rgb(0, 122, 170); font-size: 16px; letter-spacing: 0.544px; text-align: left; box-sizing: border-box !important;"><strong style="outline: 0px; max-width: 100%; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; letter-spacing: 1px; box-sizing: border-box !important;">♂</span></strong></span><span style="outline: 0px; max-width: 100%; text-align: left; box-sizing: border-box !important;"><strong style="outline: 0px; max-width: 100%; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; color: rgb(0, 122, 170); font-size: 16px; letter-spacing: 0.5px; box-sizing: border-box !important;">Q</span><span style="outline: 0px; max-width: 100%; font-size: 15px; letter-spacing: 0.544px; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; font-family: Arial, sans-serif; box-sizing: border-box !important;">406</span></span></strong></span><span style="outline: 0px; max-width: 100%; color: rgb(0, 122, 170); letter-spacing: 0.544px; text-align: left; box-sizing: border-box !important;"><strong style="outline: 0px; max-width: 100%; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; font-size: 16px; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; letter-spacing: 0.5px; box-sizing: border-box !important;"> </span><span style="outline: 0px; max-width: 100%; box-sizing: border-box !important;"><strong style="outline: 0px; max-width: 100%; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; font-size: 15px; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; color: rgb(0, 0, 0); font-family: Arial, sans-serif; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; letter-spacing: 0.5px; box-sizing: border-box !important;"> </span></span></span></strong></span></span></strong></span><strong style="outline: 0px; max-width: 100%; color: rgb(0, 122, 170); letter-spacing: 0.544px; text-align: left; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; font-size: 16px; letter-spacing: 1.8px; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; box-sizing: border-box !important;">IND申报时上游工艺通常需要对</span>哪<span style="outline: 0px; max-width: 100%; box-sizing: border-box !important;">些杂志进行ISF评估？</span></span></strong></p><section data-id="3074" style="outline: 0px; max-width: 100%; box-sizing: border-box; font-family: 微软雅黑; font-size: 14px; letter-spacing: 0.544px; font-variant-numeric: normal; font-variant-east-asian: normal; text-align: left;"><section style="margin-top: 10px; margin-bottom: 10px; outline: 0px; max-width: 100%; box-sizing: border-box;"><section style="outline: 0px; max-width: 100%; box-sizing: border-box; align-items: center; display: flex; justify-content: center;"><section data-width="100%" style="outline: 0px; max-width: 100%; box-sizing: border-box; border-bottom: 1px solid rgb(88, 88, 88); border-top: 3px solid rgb(88, 88, 88); height: 6px; width: 315.047px;"><br data-filtered="filtered" style="outline: 0px; max-width: 100%; box-sizing: border-box !important;"></section><section data-width="100%" style="outline: 0px; max-width: 100%; box-sizing: border-box; border-bottom: 1px solid rgb(88, 88, 88); border-top: 3px solid rgb(88, 88, 88); height: 6px; width: 315.047px;"><br data-filtered="filtered" style="outline: 0px; max-width: 100%; box-sizing: border-box !important;"></section><section data-width="100%" style="outline: 0px; max-width: 100%; box-sizing: border-box; border-bottom: 1px solid rgb(88, 88, 88); border-top: 3px solid rgb(88, 88, 88); height: 6px; width: 315.047px;"><br data-filtered="filtered" style="outline: 0px; max-width: 100%; box-sizing: border-box !important;"></section><section data-width="100%" style="outline: 0px; max-width: 100%; box-sizing: border-box; border-bottom: 1px solid rgb(88, 88, 88); border-top: 3px solid rgb(88, 88, 88); height: 6px; width: 315.047px;"><br data-filtered="filtered" style="outline: 0px; max-width: 100%; box-sizing: border-box !important;"></section></section></section></section></section></section></section><section powered-by="xiumi.us" style="margin-top: 10px; margin-bottom: 10px; outline: 0px; max-width: 100%; text-align: justify; box-sizing: border-box !important;"><section style="padding: 3px; outline: 0px; max-width: 100%; display: inline-block; width: 677px; vertical-align: top; border-style: solid; border-width: 1px; border-radius: 0px; border-color: rgb(0, 136, 111); box-sizing: border-box !important;"><section powered-by="xiumi.us" style="padding: 10px 15px; outline: 0px; max-width: 100%; display: inline-block; width: 669px; vertical-align: top; box-sizing: border-box !important;"><section powered-by="xiumi.us" style="outline: 0px; max-width: 100%; transform: translate3d(1px, 0px, 0px); box-sizing: border-box !important;"><section style="outline: 0px; max-width: 100%; line-height: 1.8; box-sizing: border-box !important;"><p style="margin-bottom: 10px; outline: 0px; max-width: 100%; clear: both; min-height: 1em; font-size: 13px; letter-spacing: 1.8px; text-align: -webkit-left; text-indent: 0em; box-sizing: border-box !important;"><strong style="outline: 0px; max-width: 100%; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; color: rgb(171, 25, 66); font-size: 16px; letter-spacing: 1px; box-sizing: border-box !important;">A：如下</span></strong></p><p style="margin-bottom: 10px; outline: 0px; max-width: 100%; clear: both; min-height: 1em; color: rgb(34, 34, 34); font-family: -apple-system, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; letter-spacing: 1.8px; line-height: 1.5em; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; font-size: 16px; box-sizing: border-box !important;"><strong style="outline: 0px; max-width: 100%; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; font-family: Arial, sans-serif; text-align: center; box-sizing: border-box !important;"></span></strong></span><span style="outline: 0px; max-width: 100%; font-size: 15px; letter-spacing: 1.8px; color: rgb(51, 51, 51); font-family: mp-quote, -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; color: rgb(102, 102, 102); font-family: "Helvetica Neue", "PingFang SC", STHeiti, 微软雅黑, "Microsoft YaHei", Helvetica, Arial, sans-serif; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; color: rgb(34, 34, 34); font-family: "Microsoft YaHei", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; font-size: 16px; font-weight: bold; letter-spacing: 1.8px; box-sizing: border-box !important;"><strong style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; color: rgb(51, 51, 51); font-family: mp-quote, -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; font-family: "Microsoft YaHei", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; box-sizing: border-box !important;"><strong style="outline: 0px; max-width: 100%; color: rgb(171, 25, 66); font-family: -apple-system, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; letter-spacing: 1.8px; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; font-family: "Microsoft YaHei", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; letter-spacing: 1px; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; font-weight: 400; color: rgb(62, 62, 62); letter-spacing: 0.8px; font-size: 15px; font-family: Arial, sans-serif; text-align: center; box-sizing: border-box !important;">♀ </span><strong style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; color: rgb(51, 51, 51); font-family: mp-quote, -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; letter-spacing: 1.8px; font-family: "Microsoft YaHei", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; box-sizing: border-box !important;"><strong style="outline: 0px; max-width: 100%; color: rgb(171, 25, 66); font-family: -apple-system, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; letter-spacing: 1.8px; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; font-family: "Microsoft YaHei", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; letter-spacing: 1px; box-sizing: border-box !important;">对</span></strong></span></strong></span></strong></span></strong></span></span></span><span style="outline: 0px; max-width: 100%; font-size: 15px; letter-spacing: 1.8px; color: rgb(51, 51, 51); font-family: mp-quote, -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; color: rgb(102, 102, 102); font-family: "Helvetica Neue", "PingFang SC", STHeiti, 微软雅黑, "Microsoft YaHei", Helvetica, Arial, sans-serif; box-sizing: border-box !important;">PF 68、DMSO、消泡剂、筛选压力（MSX/MTX）、其他添加物。</span></span><span style="outline: 0px; max-width: 100%; color: rgb(25, 25, 25); font-family: "PingFang SC", Arial, 微软雅黑, 宋体, simsun, sans-serif; font-size: 15px; letter-spacing: 1.8px; text-align: left; box-sizing: border-box !important;"></span></p><p style="margin-bottom: 10px; outline: 0px; max-width: 100%; clear: both; min-height: 1em; line-height: 1.5em; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; color: rgb(62, 62, 62); font-family: Arial, sans-serif; font-size: 15px; letter-spacing: 0.8px; text-align: center; box-sizing: border-box !important;">♀ </span><span style="outline: 0px; max-width: 100%; text-align: center; font-size: 16px; letter-spacing: 1px; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; color: rgb(171, 25, 66); box-sizing: border-box !important;"><b style="outline: 0px; max-width: 100%; box-sizing: border-box !important;">案例：</b></span></span></span></span></span></span></span></span></span></span></span></span></span></p><p style="margin-bottom: 0em; outline: 0px; max-width: 100%; clear: both; min-height: 1em; color: rgb(34, 34, 34); font-family: system-ui, -apple-system, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; letter-spacing: 0.544px; text-align: center; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; font-family: -apple-system, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; letter-spacing: 1.8px; text-align: justify; box-sizing: border-box !important;"></span></p><section style="margin-top: 15px; outline: 0px; max-width: 100%; font-size: 13px; letter-spacing: 1.8px; text-align: -webkit-left; box-sizing: border-box !important;"><span style="outline: 0px; max-width: 100%; text-align: center; font-weight: 700; text-indent: 34px; letter-spacing: 5px; font-family: arial, helvetica, sans-serif; box-sizing: border-box !important;"> </span><span style="outline: 0px; max-width: 100%; color: rgb(51, 51, 51); font-family: Arial, sans-serif; font-size: 15px; letter-spacing: 0.544px; box-sizing: border-box !important;"></span></section></section></section></section></section></section></section><section style="outline: 0px; letter-spacing: 0.544px; user-select: auto; line-height: 1.6; justify-content: center; max-width: 100%; max-inline-size: 100%; box-sizing: border-box !important;"><br></section></section></section></section></section></section></section></section></section></section></section></section></div> 学习了
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