FDA指南-上市后CMC变更的等同性方案 2022年10月发布

fireflame · 发表于 2022-10-16 16:17:25

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FDA Guidance for Industry - Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA

I. INTRODUCTION
This final guidance is intended to assist original applicants and holders of approved new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs) with implementing a chemistry, manufacturing, and controls (CMC) postapproval change through the use of a comparability protocol (CP).3 A CP is a comprehensive, prospectively written plan for assessing the effect of a proposed postapproval CMC change(s) on the identity, strength, quality, purity, and potency of a drug product, including a biological product (i.e., product),4 as these factors may relate to the safety or effectiveness of the product (i.e., product quality).
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小金库 · 发表于 2022-10-16 18:12:23

感谢分享

胜利者 · 发表于 2022-10-17 08:31:11

顶起

猫咪特工 · 发表于 2022-10-17 08:54:27

谢谢分享

yangzmwang · 发表于 2022-10-17 08:54:31

求中文版

Dimples. · 发表于 2022-10-17 09:03:43

感谢分享

我奥特曼有低保 · 发表于 2022-10-17 14:22:03

有无中翻版本（来自英渣的求助

chy12 · 发表于 2022-10-19 15:41:05

跪求中文版~~

郑er · 发表于 2022-11-6 15:08:40

有指南解读吗

18795777502 · 发表于 2022-11-7 16:31:26

一键翻译的中文版本，供参考

深海鱼 · 发表于 2022-11-7 16:51:24

谢谢分享！

chy12 · 发表于 2022-11-8 14:04:03

感谢分享~~~

Catherinesun · 发表于 2022-11-8 14:41:51

感谢分享

gamekyu · 发表于 2022-11-8 16:23:39

谢谢分享，学习

花园西路 · 发表于 2022-11-24 09:16:14

感谢分享！！！

振振公子 · 发表于 2023-5-21 13:13:20

谢谢分享！

振振公子 · 发表于 2023-5-22 08:24:09

谢谢分享！

caozwe · 发表于 2023-5-23 10:08:11

感谢分享感谢分享