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.
点击下载:
PDF (576KB)
返 回