VICH GL51 Quality: statistical evaluation of stability data - Scientific guideline

This document addresses the evaluation of stability data that should be submitted in registration applications for new molecular entities and associated veterinary medicinal products. It provides recommendations on establishing retest periods and shelf lives for drug substances and veterinary medicinal products intended for storage at or below room temperature. It covers stability studies using single- or multi factor designs and full or reduced designs.

Keywords: Stability, stability testing, stability data, retest period, shelf life, VICH, veterinary medicinal product (VMP)