Shelf-Life Estimation for Multifactor Stability Studies
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Shelf-Life Estimation for Multifactor Stability Studies* James J. Chen, Hongshik Ahn and Yi Tsong Drug Information Journal 1997 31: 573 DOI: 10.1177/009286159703100225 The online version of this article can be found at: http://dij.sagepub.com/content/31/2/573
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0092-8615/97 Copyright 0 1997 Drug Information Association Inc.
Drug Information Journal, Vol. 31, pp. 573-587, 1997
Printed in the USA. All rights reserved.
SHELF-LIFE ESTIMATION FOR MULTIFACTOR STABILITY STUDIES* JAMESJ.
CHEN AND
HONGSHIK AHN
Division of Biometry and Risk Assessment, National Center for Toxicological Research, Food and Drug Administration, Jefferson, Arkansas
YI TSONG Division of Biometrics 111, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland
In stability analysis, the current Food and Drug Administration (FDA) recommended procedure for estimating the expiration dating period (shelflife) of a drug is limited to a single package, single strength product. Since most drug products are manufactured with more than one strength and are marketed in more than one package, stability analyses must be carried out for every combination of package and/or strength. This paper proposes a generalization of the current FDA procedure to analyze the stability data from a multiple package and/or strength study. Monte Carlo simulation was used to address some issues with the current procedure and evaluate the proposed generalization procedure. The proposedprocedure is illustrated by an application to a data set consisting offive batches and two packages. Statistical issues and problems with the current approach of concern to industrial statisticians and the generalization are also discussed. Key Words: Analysis of covariance; Batch; Expiration dating period; Package; Strength
INTRODUCTION UNITED STATES FOOD and Drug Administration regulations require that an expiration dating period (shelf-life) be indicated on the immediate container label for every human drug and biologic on the market (1,2). The expiration dating period is defined as the time interval that a drug or biologic is expected to remain within the approved specifications after manufacture. To determine the length of time that a drug product remains within specification, a stability study is conducted to insure that the identity, strength, quality, and purity of a drug product are within established specification ranges prior to the expiration date. The stability analysis gene
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