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GUIDANCE DOCUMENT

CVM GFI #224 (VICH GL52) Bioequivalence: Blood Level Bioequivalence Study December 2016

Final
Docket Number:
FDA-2014-D-1352
Issued by:
Guidance Issuing Office
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.

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-1352.

Questions?

Contact Point
CVM
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Pl, HFV-1
Rockville, MD 20855
AskCVM@fda.hhs.gov
(240) 402-7002