Expiration Dating of Pharmaceutical Compounds in Relation to Analytical Variation, Degradation Rate, and Matrix Designs
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Expiration Dating of Pharmaceutical Compounds in Relation to Analytical Variation, Degradation Rate, and Matrix Designs Jaya Natarajan, Stan Altan and Damaraju Raghavarao Drug Information Journal 1997 31: 589 DOI: 10.1177/009286159703100226 The online version of this article can be found at: http://dij.sagepub.com/content/31/2/589
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0092-8615/97 Copyright 0 1997 Drug Information Association Inc.
Drug Information Journal, Vol. 31, pp. 589-595, 1997 Printed in the USA. All rights reserved.
EXPIRATION DATING OF PHARMACEUTICAL COMPOUNDS IN RELATION TO ANALYTICAL VARIATION, DEGRADATION RATE, AND MATRIX DESIGNS JAYA NATARAJAN, PHD, AND STANALTAN,PHD Preclinical Biostatistics Department, The R.W. Johnson Pharmaceutical Research Institute, Raritan, New Jersey
DAMARAJU RAGHAVARAO, PHD Department of Statistics, Temple University, Philadelphia, Pennsylvania
In order to establish a shelf life claim for the potency of pharmaceutical compounds drug stability studies are conducted by pharmaceutical companies. Frequently, the effects on stability of a variety offixed factors are investigated, leading to large and expensive study designs. Consequently, the use of fractional factorial or matrix designs have received increasing attention from statisticians, with a view toward managing the size of such studies. Fixed factors of interest have been studied with respect to matrixing; howevel; matrixing on the choice of time points has not been thoroughly investigated. This paper studies the effect on the expiration dating of various matrix designs specifically on the choice of sampling time points, in relation to analytical variation and degradation rate. Some useful tables are also given comparing expiration dates from matrixing across sampling time points in relation to the analytical variation and degradation rate. Key Words: Expiration dating; Stability modeling; Matrix designs; Shelf life; Degradation
INTRODUCTION PHARMACEUTICAL MANUFACTURERS are obligated by law to provide an estimate of the length of time that the active compound(s) of their marketed products maintain an acceptable level of potency (or concentration). This time estimate is referred to as the expiration date, and as such, its documentation is an essential part of the Chemistry, Manufacturing and Control (CMC) section of a New Drug Application (NDA) submitted to the Food and Drug Administration (FDA) for regulatory review. The FDA has set forth comprehensive guidelines (1, 2) for the conduct o
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