On Assessment of Bioequivalence for Drugs with Negligible Plasma Levels
作者:
Jen‐Pei Liu,
Shein‐Chung Chow,
期刊:
Biometrical Journal
(WILEY Available online 1993)
卷期:
Volume 35,
issue 1
页码: 109-123
ISSN:0323-3847
年代: 1993
DOI:10.1002/bimj.4710350111
出版商: WILEY‐VCH Verlag
关键词: Bioequivalence;Crossover;Binary data;Hazard ratio
数据来源: WILEY
摘要:
AbstractIn bioavailability studies, bioequivalence between drug products is usually determined based on some pharmacokinetic responses such as area under the blood or plasma concentration‐time curve and maximum concentration. For some drug products, however, we may have negligible plasma levels because their intended routes of administration. In this case, assessment of bioequivalence between drug products of this kind may be established using clinical endpoints such as therapeutic response and time to the onset of a therapeutic response. In this paper, we propose two procedures which modify the method of generalized estimating equations (Liang and Zeger, 1986) and the proportional hazard models for paired failure times to assess bioequivalence between two drug products under the structure of a standard two‐sequence, two‐period crossover design. An example concerning a bioequivalence trial for albuterol metered dose inhaler indicated for acute bronchospasm (Herson, 1991) is used to illustrate the proposed proce
点击下载:
PDF
(654KB)
返 回