FDA发布新的指导原则~

火飘夜

FDA Issues Guidance on Analytics and Method Validation

Jul 24, 2015

By Pharmaceutical Technology Editors

FDA has issued Analytical Procedures and Methods Validation for Drugs and Biologics, which provides recommendations for how to submit analytical procedures and methods validation data to FDA to support documentation of the identity, strength, quality, purity, and potency of drugs. The guidance supersedes a February 2014 draft guidance, replaces a 2000 draft guidance, and complements the International Conference on Harmonization’s Q2(R1) Validation of Analytical Procedures: Text and Methodology.
The guidance applies to new drug applications, abbreviated new drug applications, biologics license applications, and their supplements, as well as to drug products covered in Type II drug master files. It does not apply to investigational new drug applications; however, the guidance suggests that sponsors may consider the recommendations in the guidance. Specific method validation recommendations for biological and immunochemical assays for characterization and quality control of many drug substances and drug products are not covered in the guidance.

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM386366.pdf

完全怕猫

顶一下！

chengks

谢谢分享，下载学习。

天睦

为什么FDA的官网动不动就来一次指导原则，告诉大家这个事情FDA希望怎么做
CFDA为什么没那么麻烦过

曹小芬爱疯叮

帮忙顶一个。。

owena2013

好好学习一下

1831

学习了，但学不明白，英文啊，都忘没了

87牛

天睦 发表于 2015-7-27 13:59
为什么FDA的官网动不动就来一次指导原则，告诉大家这个事情FDA希望怎么做
CFDA为什么没那么麻烦过

....太忙，没时间啊，对吧

syhorchid

谢谢分享

半部春秋

谢谢楼主分享

郦无悔

ICH出新的了, 各大药监局就开始行动更新自己家的啦~~

天睦

87牛 发表于 2015-7-27 15:35
....太忙，没时间啊，对吧

我觉得也非常有可能是这样

一沙一叶

内容不错。   

Ivy2008

好强啊

vcjw

感谢分享  ！！
学习一下心知识，就是英文得费点劲。

husong711103

学习一下，谢谢分享

bijggm

唉，分析也是要与时俱进啊，法规时常变化。