Q4B 附录 9(R1)：片剂脆碎度通则（FDA-2009-D-0343，最终版）
Q4B Annex 9(R1): Tablet Friability General Chapter
美国 FDA 发布 Q4B 附录 9(R1)《片剂脆碎度通则》最终版指南，文件编号 FDA-2009-D-0343，由 CBER 与 CDER 共同签发。该附录属 Q4B 系列，旨在推动所选药典文本在 ICH 地区被监管机构认可为可互换使用，以避免行业重复检测。
GUIDANCE DOCUMENT
Final
- Docket Number:
- FDA-2009-D-0343
- Issued by:
-
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research
[updated 9/18/2017]
This annex is one in a series of guidance documents that describe the evaluations and recommendations by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions. Implementation of the Q4B annexes is intended to avoid redundant testing by industry. For general information on the Q4B process, the reader is referred to the core guidance Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions.
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Dockets Management
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All written comments should be identified with this document's docket number: FDA-2009-D-0343.
来源：FDA Pharmaceutical Quality Documents · fda.gov