Design and Analysis of Bioavailability and Bioequivalence Studies

DOI10.1201/9781420011678MaRDI QIDQ5503757zbMATH OpenOpenAlexFDO

Authors Shein-Chung Chow, Jenpei Liu

Publication date 16 January 2009

Full work available at URL https://doi.org/10.1201/9781420011678

Mathematics Subject Classification ID

Introductory exposition (textbooks, tutorial papers, etc.) pertaining to statistics (62-01) Applications of statistics to biology and medical sciences; meta analysis (62P10) Kinetics in biochemical problems (pharmacokinetics, enzyme kinetics, etc.) (92C45)

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Cited in

(12)

• Optimum experimental designs for comparative bioavailability studies
• Confidence region approach for assessing bioequivalence and biosimilarity accounting for heterogeneity of variability
• The predictive distribution of the residual variability in the linear-fixed effects model for clinical cross-over trials
• scientific article; zbMATH DE number 747024 (Why is no real title available?)
• scientific article; zbMATH DE number 1278892 (Why is no real title available?)
• Bioequivalence and statistics in clinical pharmacology.
• Bioequivalence Studies in Drug Development
• A new confidence interval for the ratio of two normal means and comparisons
• Improved test procedure and sample size calculation for assessing similarity in two-group comparative studies with heterogeneous variances
• Consumer's risk in the EMA and FDA regulatory approaches for bioequivalence in highly variable drugs
• The use of asymmetric distributions in average bioequivalence
• On assessing bioequivalence and interchangeability between generics based on indirect comparisons

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