FDA发布速释固体口服制剂溶出度试验最终行业指南
Dissolution Testing of Immediate Release Solid Oral Dosage Forms
FDA宣布发布《速释固体口服制剂溶出度试验》最终行业指南，文件编号 FDA-1997-D-0187。指南就溶出度试验、依据原料药生物药剂学特征设定溶出度标准、溶出曲线比较的统计方法提出建议，并给出判断溶出度试验是否足以豁免体内生物等效性研究的流程。文件还涵盖某些批准后生产变更情形下帮助确保药品质量与性能持续的溶出度试验建议。
该文件为速释固体口服制剂溶出度试验提供一般性建议，并说明何时溶出度试验可替代体内生物等效性研究。
GUIDANCE DOCUMENT
Final
- Docket Number:
- FDA-1997-D-0187
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Dissolution Testing of Immediate Release Solid Oral Dosage Forms.'' The purpose of this guidance document is to provide general recommendations for dissolution testing, approaches for setting dissolution specifications related to biopharmaceutic characteristics of the drug substance, statistical methods for comparing dissolution profiles, and a process to help determine when dissolution testing is sufficient to grant a waiver for an in vivo bioequivalence study. This guidance document also provides recommendations for dissolution tests to help ensure continuous drug product quality and performance after certain postapproval manufacturing changes.
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-1997-D-0187.
来源：FDA Pharmaceutical Quality Documents · fda.gov