Establishing Shelf Life, Expiry Limits, and Release Limits
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Establishing Shelf Life, Expiry Limits, and Release Limits John R. Murphy and Jeffrey D. Hofer Drug Information Journal 2002 36: 769 DOI: 10.1177/009286150203600407 The online version of this article can be found at: http://dij.sagepub.com/content/36/4/769
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Drug Infomarion Jorrmnl. Vd. 36, pp. 769-781,2002 Printed in the USA. All rights reserved.
0092-8615/2002 Copyright 0 2002 Drug Information Association Inc.
ESTABLISHING SHELF LIFE, EXPIRY LIMITS, AND RELEASE LIMITS JOHN R. MURPHYAND JEFFREY D. HOFER Lilly Research Laboratories, Eli Lilly and Company, Indianapolis Indiana
Recent intemtional harmonization efforts such as the International Conference on Harmonization (ICH)Harmonized Tripartite Guideline: Q6A, Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances have provided general guidance for setting specijications f o r new drug substances and drug products, but have not provided statistical methods for integrating stability results into the process, The only statistical methods are those provided in the ICH Harmonized Tripartite Guideline: Ql(R), Stability Testing of New Drug Substances and Products (Revised guideline), which are essentially the same as those contained in the 1987 US.Food and Drug Administration (FDA)Guidelines for Submitting Documentation for the Stability of Human Drugs and Biologics. Although these methods are widely used, they have continued to be a source of controversy, and they are unsuitable for establishing specifications at the time of submission. This paper provides a new computational method for determining shelf life, expiry limits, and release limits using random slopes based upon h a s t Squares ANOVA Estimators. Examples are provided to illustrate how the new method m y be used to assist in setting specifications according to the recommendations in Q6A. Key Words: Shelf life; Expiry limits; FDA stability method; ICH QI(R); ICH Q6A; ICH Q6B; Random slopes; Mixed models; Acceptance criteria
INTRODUCTION
of shelf life, expiry limits, and release limits must be addressed early in the development BEFORE A DRUG CAN be marketed in the process and must be revisited periodically United States, an appropriate shelf life must throughout the life of the product. At present, be determined, and expiry limits must be esthere is no universally recognized method for tablished for the relevant analytical properdetermining shelf life, expiry specifica
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