Conduct of bioequivalence studies for veterinary medicinal products - Scientific guideline

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, generic veterinary medicinal product, predefined acceptance criteria, biowaiver, in vitro dissolution tests

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