FDA发布口服缓释制剂体外/体内相关性（IVIVC）最终指南
Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations
FDA发布口服缓释制剂体外/体内相关性（IVIVC）最终指南，面向拟在NDA、ANDA或AADA中提交IVIVC资料的申办方。指南涵盖IVIVC的建立方法与可预测性评价，以及用IVIVC设定溶出度标准。文件还说明在初始批准或处方、设备、工艺和生产场地等批准前后变更时，可将IVIVC作为体内生物等效性的替代。
指南列出IVIVC的开发与可预测性评价方法，并说明其用于设定溶出度标准及作为体内生物等效性替代的情形。
GUIDANCE DOCUMENT
Final
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
This guidance provides recommendations to pharmaceutical sponsors who intend to develop documentation in support of an in vitro/in vivo correlation (IVIVC) for an oral extended release (ER) drug product for submission in a new drug application (NDA), abbreviated new drug application (ANDA), or antibiotic drug application (AADA). The guidance presents a comprehensive perspective on (1) methods of developing an IVIVC and evaluating its predictability; (2) using an IVIVC to set dissolution specifications; and (3) applying an IVIVC as a surrogate for in vivo bioequivalence when it is necessary to document bioequivalence during the initial approval process or because of certain pre- or postapproval changes (e.g., formulation, equipment, process, and manufacturing site changes).
Submit Comments
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
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 comments should be identified with the title of the guidance.
来源：FDA Pharmaceutical Quality Documents · fda.gov