VICH GL43 Target animal safety: pharmaceuticals - Scientific guideline
Table of contents
This document provides recommendations regarding target animal safety (TAS) evaluation for regulatory submission of an investigational veterinary pharmaceutical product (IVPP), which is appropriate for determining the safety of an IVPP in the target animal. It aims to facilitate the mutual acceptance of TAS data by the regulatory authorities in the VICH regions.
Keywords: Target animal safety (TAS), investigational veterinary pharmaceutical product (IVPP), VICH, veterinary medicinal product (VMP)