A Related Problem in Bioavailability/Bioequivalence Studies — Estimation of the Intrasubject Variability With a Common CV

✍ Scribed by Dr. Shein-Chung Chow; Dr. Siu-Keung Tse

• Publisher: John Wiley and Sons
• Year: 2007
• Tongue: English
• Weight: 582 KB
• Volume: 32
• Category: Article
• ISSN: 0323-3847
• DOI: 10.1002/bimj.4710320511

✦ Synopsis

The problem of characterizing the intrasubject variability in bioavai~ability/bioequivalence strtdies when the intraaubject variability differs from subject to subject is considered. To account for the heterogeneity of the intrasubject variability, a conditional random effects model that assumes a common coefficient of variation (CV) for each subject is proposed. This commonCV is used to assess the intrasubject variability. Several procedures are developed for estimating the common CV. The proposed estimators are compared asymptotically. An extensive siniulation study is conducted to study their finite sample performances.