FDA发布Q4B附录5(R1)崩解试验通则最终指南
Q4B Annex 5(R1): Disintegration Test General Chapter
FDA发布Q4B附录5(R1)崩解试验通则最终指南，该附录属Q4B系列，用于推动药典文献在ICH区域作为可互换文本获得监管机构认可。Q4B附录的实施意在避免行业重复检测，文件案卷编号为FDA-2008-D-0399。FDA表示可随时对任何指南提交评议，书面评议须标注该案卷编号。
GUIDANCE DOCUMENT
Final
- Docket Number:
- FDA-2008-D-0399
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics 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.
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-2008-D-0399.
来源：FDA Pharmaceutical Quality Documents · fda.gov