VICH GL52 Bioequivalence: blood level bioequivalence study - Scientific guideline

This document aims to harmonize the data requirements associated with in vivo blood level bioequivalence for veterinary pharmaceutical products.

Keywords: Bioequivalence (BE), bioequivalence study design, blood level bioequivalence, bioavailability, biowaiver, VICH, veterinary medicinal product (VMP)

Current effective version

International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products GL52 on bioequivalence: blood-level bioequivalence study

AdoptedReference Number: EMA/CVMP/VICH/751935/2013

Document history

Draft International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products GL52 on bioequivalence: blood-level bioequivalence study

Draft: consultation closedConsultation dates: 16/12/2013 to 31/05/2014Reference Number: EMA/CVMP/VICH/751935/2013Summary:

This guideline is intended to harmonise the data requirements associated with in vivo blood-level bioequivalence (BE) for veterinary pharmaceutical products.