Bioequivalence Studies in Drug Development

DOI10.1002/9780470094778MaRDI QIDQ5309796zbMATH OpenOpenAlexFDO

Authors Dieter Hauschke, Volker W. Steinijans, Iris Pigeot-Kübler

Publication date 2 October 2007

Full work available at URL https://doi.org/10.1002/9780470094778

zbMATH Keywords

bioequivalencedrug developmentnonparametric statistical techniques

Mathematics Subject Classification ID

Medical applications (general) (92C50) Biochemistry, molecular biology (92C40) Research exposition (monographs, survey articles) pertaining to biology (92-02) Kinetics in biochemical problems (pharmacokinetics, enzyme kinetics, etc.) (92C45)

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Cited in

(22)

• Power analysis of approximation methods for parameter estimation in Cox regression model with longitudinal covariate and tied survival times
• Comparing regression curves: an \(L^1\)-point of view
• On testing the bioequivalence of several treatments using the measure of distance
• Equivalence of regression curves
• scientific article; zbMATH DE number 6672845 (Why is no real title available?)
• Design and Analysis of Bioavailability and Bioequivalence Studies
• Assessing Bioavailablility of Drug Delivery Systems
• On Testing the Mean Equivalence of Treatments from Correlated Normal Populations
• Statistical Design and Analysis of Stability Studies
• Similarity of competing risks models with constant intensities in an application to clinical healthcare pathways involving prostate cancer surgery
• Improved test procedure and sample size calculation for assessing similarity in two-group comparative studies with heterogeneous variances
• scientific article; zbMATH DE number 747024 (Why is no real title available?)
• Analytical similarity assessment in biosimilar product development
• On bilateral selection \(t\) model and its application to inequality constrained problems
• Bioequivalence and statistics in clinical pharmacology.
• Some factors affecting statistical power of approximate tests in the linear mixed model for longitudinal data
• Hypothesis Testing for Equivalence Defined on Symmetric Open Intervals
• Iterated bootstrap procedure in individual bioequivalence
• Biosimilars. Design and analysis of follow-on biologics
• Testing the Equivalence of Generalized Variances in Multivariate Bioequivalence
• Bayesian methods for bioequivalence studies
• Pilot-pivotal trials for average bioequivalence

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