FDA 发布 Q1E 稳定性数据评价最终指南

Q1E Evaluation of Stability Data

AI 导读

FDA 发布 Q1E 稳定性数据评价最终指南，文件编号 FDA-2002-D-0180，由 CDER 与 CBER 发布。指南说明如何依据 ICH 指南 Q1A(R2) 产生的稳定性数据，在注册申请中拟定原料药复检期或制剂货架期。文件还说明在长期贮藏条件下所得数据的覆盖期之外提出复检期或货架期时，何时以及如何考虑外推。

推荐理由

该文件说明如何依据 ICH Q1A(R2) 稳定性数据拟定复检期或货架期，并界定何时可考虑外推。

正文 · 原文

GUIDANCE DOCUMENT

Final

Docket Number:

FDA-2002-D-0180

Issued by:

Guidance Issuing Office

Center for Drug Evaluation and Research

Center for Biologics Evaluation and Research

This guidance provides recommendations on how to use stability data generated in accordance with the principles detailed in the ICH guidance Q1A(R2) Stability Testing of New Drug Substances and Products (parent guidance) to propose a retest period or shelf life in a registration application. This guidance describes when and how extrapolation can be considered when proposing a retest period for a drug substance or a shelf life for a drug product that extends beyond the period covered by available data from the stability study under the long-term storage condition (long-term data).

Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2002-D-0180.