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Assessing Distributions of Estimated Drug Shelf Lives in Stability Analysis
Author(s) -
Sun Yanqing,
Chow SheinChung,
Li Gang,
Chen KehWei
Publication year - 1999
Publication title -
biometrics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.298
H-Index - 130
eISSN - 1541-0420
pISSN - 0006-341X
DOI - 10.1111/j.0006-341x.1999.00896.x
Subject(s) - expiration date , stability (learning theory) , shelf life , off the shelf , statistics , computer science , biometrics , econometrics , mathematics , artificial intelligence , engineering , machine learning , chemistry , mechanical engineering , food science , software engineering
Summary. A stability study is usually conducted to ensure that a drug product can meet the approved specifications prior to its expiration dating period (shelf life). Several approaches for determination of drug shelf life assuming random batches have been proposed. In this paper, we examine sampling distributions of the estimated shelf lives proposed by Shao and Chow (1994, Biometrics 50 , 753–763). An application to some stability data from the pharmaceutical industry is presented.