GUIDANCE DOCUMENT
CVM GFI #35 Bioequivalence Guidance November 2006
- Docket Number:
- FDA-1994-D-0317
- Issued by:
-
Guidance Issuing OfficeCenter for Veterinary Medicine
This document is intended to provide guidance for the design and analysis of in vivo bioequivalence studies.
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-1994-D-0317.