VICH GL52 Bioequivalence: blood level bioequivalence study - Scientific guideline

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Current effective version
Document history

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

List item

International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products GL52 on bioequivalence: blood-level bioequivalence study (PDF/330.75 KB)

Adopted

First published: 17/09/2015
Last updated: 17/09/2015
EMA/CVMP/VICH/751935/2013

Document history

List item

Draft International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products GL52 on bioequivalence: blood-level bioequivalence study (PDF/237.82 KB)

Draft: consultation closed

First published: 16/12/2013
Last updated: 16/12/2013
Consultation dates: 16/12/2013 to 31/05/2014
EMA/CVMP/VICH/751935/2013

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Scientific guidelines

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