（推荐）临床早期（I期， IIa期）appropriate GMPs系列文章

beiwei5du · 发表于 2017-10-7 18:01:30

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本帖最后由 beiwei5du 于 2017-10-7 18:02 编辑

以下临床早期（I期， IIa期）appropriate GMPs系列文章,供参考！
GMPs for small-molecule drugs in early development
http://www.pharmtech.com/gmps-small-molecule-drugs-early-development-part-i
GMPs for Method Validation in Early Development: An Industry Perspective, Part II
http://www.pharmtech.com/gmps-method-validation-early-development-industry-perspective-part-ii
Early Development GMPs for Drug-Product Manufacturing of Small Molecules: An Industry Perspective, Part III
http://www.pharmtech.com/early-development-gmps-drug-product-manufacturing-small-molecules-industry-perspective-part-iii
Early Development GMPs for Stability, Part IV Early Development GMPs for Small-Molecule Specifications: An Industry Perspective, Part V
http://www.pharmtech.com/early-development-gmps-small-molecule-specifications-industry-perspective-part-v
GMPs for Small-Molecule Drugs in Early Development: Workshop Summary, Part VI
http://www.pharmtech.com/gmps-small-molecule-drugs-early-development-workshop-summary-part-vi
GMPs for Small Molecule Drugs in Early Development: Workshop Summary, Part VII
http://www.pharmtech.com/part-vii-gmps-small-molecule-drugs-early-development-workshop-summary

beiwei5du · 发表于 2017-10-7 23:53:09

Because of changes in synthetic routes and formulations, the impurities and degradation products formed may change during development. Accordingly, related substances are often determined using area percentage by assuming that the relative response factors are similar to that of the API. If the same assumption is used to conduct the analyses and in toxicological impurity evaluation and qualification, any subsequent impurity level corrections using relative response factors are self-corrective and hence mitigate the risk that subjects would be exposed to unqualified impurities. As a result, extensive studies to demonstrate mass balance are typically not conducted during early development.
这句话如何理解呢？？？
http://www.pharmtech.com/gmps-method-validation-early-development-industry-perspective-part-ii?pageID=2

syhorchid · 发表于 2017-10-7 23:50:50

学习一下

beiwei5du · 发表于 2017-10-8 17:39:03

第三篇对于manufacturing层面还是很有价值的，框架贴出来；

套路 · 发表于 2018-1-4 13:57:26

学习学习

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hhxx2018 · 发表于 2018-8-20 13:13:50

大咖，牛，学习。

罗伊鲱 · 发表于 2018-11-7 14:34:11

Phase-Appropriate GMP
http://www.pharmtech.com/phase-appropriate-gmp-0

鍜垮憖鍜垮憖鍝 · 发表于 2019-4-17 16:15:32

学习学习一下

li123ms · 发表于 2019-4-17 16:30:01

牛，目前正需要学习。

小金库 · 发表于 2022-9-23 19:22:12

非常给力的资料,多谢分享

henryizhao · 发表于 2022-11-7 17:29:39

很好的材料，学习了

小金库 · 发表于 2022-12-16 22:25:41

谢谢分享

[GMP相关] （推荐）临床早期（I期， IIa期）appropriate GMPs系列文章

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