| 3 | 1/1 | 返回列表 |
| 查看: 1026 | 回復(fù): 2 | |||
夢游娃娃木蟲 (小有名氣)
火星奔往地球路上
|
[求助]
ICH中關(guān)于生物藥的定義 已有1人參與
|
| 急求大神們幫助。有沒有人知道ICH中關(guān)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(xué)藥,大于35個為生物藥? |

金蟲 (著名寫手)
|
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)
| 3 | 1/1 | 返回列表 |
| 最具人氣熱帖推薦 [查看全部] | 作者 | 回/看 | 最后發(fā)表 | |
|---|---|---|---|---|
|
[考研] 0703 化學(xué) 求調(diào)劑,一志愿山東大學(xué) 342 分 +4 | Shern—- 2026-03-28 | 4/200 |
|
|---|---|---|---|---|
|
[考研] 22408 359分調(diào)劑 +4 | Qshers 2026-03-27 | 5/250 |
|
|
[考研] 085701環(huán)境工程,267求調(diào)劑 +16 | minht 2026-03-26 | 16/800 |
|
|
[考研] 081200-314 +3 | LILIQQ 2026-03-27 | 4/200 |
|
|
[考研] 330一志愿中國海洋大學(xué) 化學(xué)工程 085602 有讀博意愿 求調(diào)劑 +3 | wywy.. 2026-03-27 | 4/200 |
|
|
[考研] 復(fù)試調(diào)劑,一志愿南農(nóng)083200食品科學(xué)與工程 +5 | XQTJZ 2026-03-26 | 5/250 |
|
|
[考研] 調(diào)劑 +3 | 李嘉圖·S·路 2026-03-27 | 3/150 |
|
|
[論文投稿] Journal of Mechanical Science and Technology +3 | Russ_ss 2026-03-25 | 5/250 |
|
|
[考研] 317求調(diào)劑 +7 | 蛋黃咸肉粽 2026-03-26 | 7/350 |
|
|
[考研] 325求調(diào)劑 +5 | 李嘉圖·S·路 2026-03-23 | 5/250 |
|
|
[考研] 【雙一流院校新能源、環(huán)境材料,材料加工與模擬招收大量調(diào)劑】 +4 | Higraduate 2026-03-22 | 8/400 |
|
|
[考研] 281求調(diào)劑 +3 | 亞克西good 2026-03-26 | 5/250 |
|
|
[考研] 求b區(qū)院校調(diào)劑 +4 | 周56 2026-03-24 | 5/250 |
|
|
[考研] 0854人工智能方向招收調(diào)劑 +4 | 章小魚567 2026-03-24 | 4/200 |
|
|
[考研] 318求調(diào)劑 +3 | plum李子 2026-03-23 | 3/150 |
|
|
[考研] 化工專碩求調(diào)劑 +3 | question挽風(fēng) 2026-03-24 | 3/150 |
|
|
[考研] 一志愿河北工業(yè)大學(xué)0817化工278分求調(diào)劑 +7 | jhybd 2026-03-23 | 12/600 |
|
|
[考研] 材料/農(nóng)業(yè)專業(yè),07/08開頭均可,過線就行 +3 | 呵唔哦豁 2026-03-23 | 4/200 |
|
|
[考研] 361求調(diào)劑 +3 | Glack 2026-03-22 | 3/150 |
|
|
[考研] 石河子大學(xué)(211、雙一流)碩博研究生長期招生公告 +3 | 李子目 2026-03-22 | 3/150 |
|