VICH GL52 Bioequivalence: blood level bioequivalence study

Current effective version

PDF icon Adopted guideline

Reference numberEMA/CVMP/VICH/751935/2013 – Corr.1
Effective from01/08/2016
KeywordsBioequivalence (BE), bioequivalence study design, blood level bioequivalence, bioavailability, biowaiver, VICH, veterinary medicinal product (VMP)
DescriptionThis document aims to harmonize the data requirements associated with in vivo blood level bioequivalence for veterinary pharmaceutical products.

Document history

First version

Current version

PDF icon Adopted guideline


PDF icon Draft guideline

In operation: 01/08/2016


Published: 31/05/2014

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