FDA 发布 Q1C 新剂型稳定性测试指南（FDA-2013-S-0610）

Q1C Stability Testing for New Dosage Forms

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FDA 发布 Q1C《新剂型稳定性测试》指南文件，文件编号 FDA-2013-S-0610，由生物制品评价与研究中心（CBER）和药品评价与研究中心（CDER）共同发布。该文件是 ICH 新原料药及产品稳定性测试三方协调指南的附件，针对原始申请提交后、原申请持有人就新剂型稳定性应提交的内容提出建议。公众可随时通过在线或书面方式提交意见，书面意见须注明文件编号 FDA-2013-S-0610。

正文

GUIDANCE DOCUMENT

Final

Docket Number:

FDA-2013-S-0610

Issued by:

Guidance Issuing Office

Center for Biologics Evaluation and Research

Center for Drug Evaluation and Research

This document is an annex to the ICH Harmonized Tripartite Guideline on Stability Testing of New Drug Substances and Products and addresses the recommendations on what should be submitted regarding stability of new dosage forms by the owner of the original application, after the original submission for new drug substances and products.

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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-2013-S-0610.