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梦游娃娃

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火星奔往地球路上

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[求助] ICH中关于生物药的定义已有1人参与

急求大神们帮助。有没有人知道ICH中关于生物药的定义在哪部分？有没有一个说法是小于35个氨基酸序列的多肽为化学药，大于35个为生物药？

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火星奔往地球路上

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已阅回复此楼关注TA 给TA发消息送TA红花 TA的回帖

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梦游娃娃: 金币+15, ★有帮助 2015-11-03 09:42:26

ICH Q5主讲生物制品，但是没有明确定义生物制品的概念，FDA官网有明确解释
Biological products, or biologics, are medical products. Many biologics are made from a variety of natural sources (human, animal or microorganism). Like drugs, some biologics are intended to treat diseases and medical conditions. Other biologics are used to prevent or diagnose diseases. Examples of biological products include
vaccines
blood and blood products for transfusion and/or manufacturing into other products
allergenic extracts, which are used for both diagnosis and treatment (for example, allergy shots)
human cells and tissues used for transplantation (for example, tendons, ligaments and bone)
gene therapies
cellular therapies
tests to screen potential blood donors for infectious agents such as HIV