Bioequivalence studies in drug development : methods and applications /
Hauschke, Dieter.
Steinijans, Volker.
Pigeot, Iris.
Chichester : Wiley,
c2007.
Includes bibliographical references and indexes.
Metrics to characterize concentration-time profiles in single- and multiple-dose bioequivalence studies -- Basic statistical considerations -- Assessment of average bioequivalence in the RT/TR design -- Power and sample size determination for testing average bioequivalence in the RT/TR design -- Presentation of bioequivalence studies -- Designs with more than two formulations -- Analysis of pharmacokinetic interactions -- Population and individual bioequivalence -- Equivalence assessment for clinical endpoints.
Drugs