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GUIDANCE DOCUMENT

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

Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2012-D-0288
Issued by:
Guidance Issuing Office
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.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2012-D-0288.

Questions?

Contact Point
Mai Huynh
Center for Veterinary Medicine
Office of New Animal Drug Evaluation
Food and Drug Administration
7500 Standish Place, HFV-140
Rockville, MD 20855
Mai.Huynh@fda.hhs.gov
240-402-0669