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夢游娃娃木蟲 (小有名氣)
火星奔往地球路上
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[求助]
ICH中關于生物藥的定義 已有1人參與
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| 急求大神們幫助。有沒有人知道ICH中關于生物藥的定義在哪部分?有沒有一個說法是小于35個氨基酸序列的多肽為化學藥,大于35個為生物藥? |

金蟲 (著名寫手)
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ICH Q5主講生物制品,但是沒有明確定義生物制品的概念,F(xiàn)DA官網(wǎng)有明確解釋 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 |

鐵桿木蟲 (知名作家)
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