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A comparison of expiration dating period estimation methods

 

作者: Mohammad A. Rahman,  

 

期刊: Journal of Biopharmaceutical Statistics  (Taylor Available online 1992)
卷期: Volume 2, issue 1  

页码: 69-82

 

ISSN:1054-3406

 

年代: 1992

 

DOI:10.1080/10543409208835031

 

出版商: Marcel Dekker, Inc.

 

关键词: Expiration dating period;Stability study;Degradation line

 

数据来源: Taylor

 

摘要:

Two methods of estimating expiration date have been compared. For a drug whose potency is expected to decrease with time, method 1 fits a linear regression line to the stability data, calculates a 95% lower confidence limit of the true degradation line, and estimates the expiration date by comparing the confidence limit with the lower specification limit. Method 2 calculates a 95% lower confidence limitb1of the slope of the true degradation line, constructs a new line y” usingb1as its slope, and finally estimates the expiration date by comparing y” with the lower specification limit. In this work we show that in most practical situations, method 1 estimates greater expiration date than method 2.

 

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