VICH GL51 Quality: statistical evaluation of stability data - Scientific guideline
Table of contents
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)
-
List item
VICH GL51: Quality: statistical evaluation of stability data (PDF/199.74 KB)
Adopted
First published: 13/03/2013
Last updated: 13/03/2013
EMA/CVMP/VICH/858875/2011 -
List item
Overview of comments received on VICH guideline on statistical evaluation of stability data (GL 51) (PDF/178.41 KB)
First published: 29/05/2015
Last updated: 29/05/2015
VICH GL-51 -
List item
Draft VICH GL51: Quality: statistical evaluation of stability data (PDF/213.06 KB)
Draft: consultation closed
First published: 20/12/2011
Last updated: 20/12/2011
Consultation dates: 08/12/2011 to 12/06/2012
EMA/CVMP/VICH/858875/2011