VICH GL17 Stability testing of biotechnological/biological veterinary medicinal products - Scientific guideline
Table of contents
This document provides guidance on the type of stability studies that should be provided in support of marketing applications. It applies to products composed of well characterised proteins and polypeptydes, and their derivatives which are isolated from tissues, body fluids, cell cultures, or produced using recombinant deoxyribonucleic acid (r-DNA) technology.
Keywords: VICH, stability studies, biological, biotechnological, veterinary products