- Docket Number:
- Issued by:
Guidance Issuing OfficeOffice of Foods and Veterinary Medicine, Center for Veterinary Medicine
This guidance is intended to harmonize the data recommendations associated with in vivo blood level bioequivalence (BE) for veterinary pharmaceutical products. To meet this objective, the guidance addresses the following topics:
- A harmonized definition of BE.
- Factors/variables that should be considered when developing scientifically sound blood level BE study designs.
- Information that should be included in a blood level BE study report.
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:
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-1352.