金币
UID176556
帖子
主题
积分25187
注册时间2014-6-6
最后登录1970-1-1
听众
性别保密
|
发表于 2017-10-12 11:06:06
|
显示全部楼层
FDA的法规应该是相对其他地方比较完备的了,其关于临床的法规指南大概如下,仅供参考:
AP
Q7A CHAPTER 12 APIs FOR USE IN CLINICAL TRIALS
phase 1
Guidance for Industry CGMP for Phase 1 Investigational Drugs
Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including WellCharacterized, Therapeutic, Biotechnology-derived Products
phase 2 and 3
Preparation of Investigational New Drug Products (Human and Animal)
FDA CFR 21 part 210&211
INDs for Phase 2 and Phase 3 Studies Chemistry, Manufacturing, and Controls Information
其实针对于特别是phase 1以及phase 2a的相关appropriate GMP指南到现在也不是完全统一一致的,可以参考一下:https://www.ouryao.com/forum.php?mod=viewthread&tid=396051&highlight=%C1%D9%B4%B2其中关于生产的Early Development GMPs for Drug-Product Manufacturing of Small Molecules: An Industry Perspective, Part III(小分子)。同时在Guidance for Industry CGMP for Phase 1 Investigational Drugs 中有提及到FDA会进一步对phase 2和phase 3的GMP明确(因为part210&211也不完全适用于phase 2和phase 3),但是现在好像还没有看到相关的指南。至于大分子生物药的不是很清楚。以上仅为个人汇总,仅供参考。
关于生物大分子的,可以帮call老师@仲夏秋夜云 @叶非
|
|