VICH GL39 Test procedures and acceptance criteria for new veterinary drug substances and new medicinal products: chemical substances - Scientific guideline
Table of contents
This document provides guidance on the setting and justification of acceptance criteria and the selection of test procedures for new drug substances of synthetic chemical origin and new medicinal products produced from them, which have not been registered previously in the United States, the European Union, or Japan.
Keywords: Specification, active substance, finished product, chemical, control, test, acceptance criteria, limit, release, VICH, veterinary medicinal product (VMP)