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The assessment of individual and population bioequivalence

 

作者: Vernon M. Chinchilli,  

 

期刊: Journal of Biopharmaceutical Statistics  (Taylor Available online 1996)
卷期: Volume 6, issue 1  

页码: 1-14

 

ISSN:1054-3406

 

年代: 1996

 

DOI:10.1080/10543409608835118

 

出版商: Marcel Dekker, Inc.

 

关键词: Prescribability;Switchability;Crossover design;Order statistics;Bootstrapping;Nuisance parameters

 

数据来源: Taylor

 

摘要:

We develop a statistical methodology for the assessment of individual bioequivalence when a crossover design is invoked. The location parameters for our model consist of population-averaged parameters for formulation, population-averaged parameters for nuisance effects (sequence, period, carryover, etc.), and subject-specific parameters for formulation. We do not impose any distributional assumptions other than the existence of first- and second-order moments. We derive unbiased estimators for all of the parameters in the model and construct subject-specific bioequivalence scores which exclude the effects of the nuisance parameters. We assess individual bioequivalence by constructing distribution-free tolerance intervals based on the sample of bioequivalence scores.

 

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