CVM GFI #219 (VICH GL51) Statistical Evaluation of Stability Data May 2014

GUIDANCE DOCUMENT

• Docket Number: FDA-2012-D-0288
• Issued by: Center for Veterinary Medicine

This guidance is intended to provide recommendations on how to use stability data generated in accordance with the principles detailed in the VICH guidance entitled, “Stability Testing of New Veterinary Drug Substances and Medicinal Products, GL3(R)” (hereafter referred to as the parent guidance) to propose a retest period or shelf life in a registration application. This guidance describes when and how extrapolation can be considered when proposing a retest period for a drug substance or a shelf life for a veterinary medicinal product that extends beyond the period covered by available data from the stability study under the long-term storage condition (hereafter referred to as long-term data). Application of this guidance is entirely optional and it is up to the applicant to decide whether or not to use statistical analysis to support the claimed retest period/shelf-life.

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