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Details

Guidance for Industry: Statistical Evaluation of Stability Data, VICH GL51.

PB2015100160

Publication Date	2014
Page Count	19
Abstract	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.
Keywords	Industry guidance Drug industry Veterinary medicine Applications Evaluation Extrapolitan Shell life Stability Storage Statistical analysis Testing Veterinary drugs Medicinal products
Source Agency	Center for Veterinary Medicine
NTIS Subject Category	98E - Animal Husbandry & Veterinary Medicine 57Q - Pharmacology & Pharmacological Chemistry
Corporate Authors	Food and Drug Administration, Rockville, MD. Center for Veterinary Medicine.
Document Type	Technical Report
NTIS Issue Number	201501

Guidance for Industry: Statistical Evaluation of Stability Data, VICH GL51.

Guidance for Industry: Statistical Evaluation of Stability Data, VICH GL51.
PB2015100160

Publication Date	2014
Page Count	19
Abstract	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.
Keywords	Industry guidance Drug industry Veterinary medicine Applications Evaluation Extrapolitan Shell life Stability Storage Statistical analysis Testing Veterinary drugs Medicinal products
Source Agency	Center for Veterinary Medicine
NTIS Subject Category	98E - Animal Husbandry & Veterinary Medicine 57Q - Pharmacology & Pharmacological Chemistry
Corporate Authors	Food and Drug Administration, Rockville, MD. Center for Veterinary Medicine.
Document Type	Technical Report
NTIS Issue Number	201501