FDA发布面向IND、NDA及NDA补充申请的BA和BE研究指南草案
Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs — General Considerations
FDA宣布可获取一份生物利用度（BA）和生物等效性（BE）研究指南草案，适用于IND、NDA及NDA补充申请。草案为计划在这些申报中纳入BA和BE信息的申办者提供建议，并修订2003年3月口服制剂BA和BE研究指南中的相关部分。文件编号为FDA-2014-D-0204，属草案性质，含非约束性建议，不用于实施。
草案说明了其与2003年3月口服制剂BA和BE指南相关部分的修订关系，便于申请人核对新旧文件的适用范围。
GUIDANCE DOCUMENT
Draft
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- FDA-2014-D-0204
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs—General Considerations” (draft BA and BE guidance for NDAs). The draft guidance provides recommendations to sponsors and/or applicants planning to include bioavailability (BA) and bioequivalence (BE) information for drug products in investigational new drug applications (INDs), new drug applications (NDAs), and NDA supplements. This draft guidance revises those parts of the March 2003 guidance entitled “Bioavailability and Bioequivalence Studies for Orally Administered Drug Products—General Considerations” relating to BA and BE studies for INDs, NDAs, and NDA supplements.
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-2014-D-0204.
来源：FDA Pharmaceutical Quality Documents · fda.gov