Conduct of bioequivalence studies for veterinary medicinal products

This document specifies requirements for the design, conduct, and evaluation of bioequivalence studies for pharmaceutical forms with systemic action. It also explains how in-vitro data in specific cases may be used to allow bridging of safety and efficacy data.

Keywords: Bioequivalence, pharmacokinetics, biowaiver, BCS-based biowaiver, in vitro dissolution, generics, veterinary medicinal product (VMP)

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