首页   按字顺浏览 期刊浏览 卷期浏览 Discussion of individual bioequivalence by M.-L. chen
Discussion of individual bioequivalence by M.-L. chen

 

作者: A.Lawrence Gould,  

 

期刊: Journal of Biopharmaceutical Statistics  (Taylor Available online 1997)
卷期: Volume 7, issue 1  

页码: 23-29

 

ISSN:1054-3406

 

年代: 1997

 

DOI:10.1080/10543409708835165

 

出版商: Marcel Dekker, Inc.

 

关键词: Bioavailability;Average bioequivalence;Individual bioequivalence;Mixed models;Intrasubject variability

 

数据来源: Taylor

 

摘要:

We review and discuss some technical statistical issues and practical implementation issues associated with the use of individual as opposed to population average bioequivalence to express the relative bioavailabilities of alternative formulations of a drug. A number of promising methods for addressing individual bioequivalence have been described. Individual bioequivalence calculations can be done using standard crossover designs, although more sophisticated assessments that compare test-reference variability to reference-reference variability require more complex designs. However, more experience about the clinical implications of various degrees of individual bioinequivalence as expressed by various metrics should be accumulated before definitive regulations are set forth mandating the use of individual bioequivalence for expressing relative bioavailabilities.

 

点击下载:  PDF (356KB)



返 回