Document Detail

Assessing distributions of estimated drug shelf lives in stability analysis.
MedLine Citation:
PMID:  11315024     Owner:  NLM     Status:  MEDLINE    
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.
Y Sun; S C Chow; G Li; K W Chen
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Biometrics     Volume:  55     ISSN:  0006-341X     ISO Abbreviation:  Biometrics     Publication Date:  1999 Sep 
Date Detail:
Created Date:  2001-04-20     Completed Date:  2001-08-16     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0370625     Medline TA:  Biometrics     Country:  United States    
Other Details:
Languages:  eng     Pagination:  896-9     Citation Subset:  IM    
Department of Mathematics, University of North Carolina, Charlotte 28223, USA.
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MeSH Terms
Drug Industry
Drug Stability*
Models, Statistical
Time Factors

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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