Bioequivalence Studies in Drug Development / Statistics in Practice (PDF)

Preface. 1 Introduction. 1.1 Definitions. 1.2 When are bioequivalence studies performed. 1.3 Design and conduct of bioequivalence studies. 1.4 Aims and structure of the book. References. 2 Metrics to characterize concentration-time profiles in single- and multiple-dose bioequivalence studies. 2.1 Introduction. 2.2 Pharmacokinetic characteristics (metrics) for single-dose studies. 2.3 Pharmacokinetic rate and extent characteristics (metrics) for multiple-dose studies. 2.4 Conclusions. References. 3 Basic statistical considerations. 3.1 Introduction. 3.2 Additive and multiplicative model. 3.3 Hypotheses testing. 3.4 The RT/TR crossover design assuming an additive model. References. 4 Assessment of average bioequivalence in the RT/TR design. 4.1 Introduction. 4.2 The RT/TR crossover design assuming a multiplicative model. 4.3 Test procedures for bioequivalence assessment. 4.4 Conclusions. References. 5 Power and sample size determination for testing average bioequivalence in the RT/TR design. 5.1 Introduction. 5.2 Challenging the classical approach. 5.3 Exact power and sample size calculation. 5.4 Modified acceptance ranges. 5.5 Approximate formulas for sample size calculation. 5.6 Exact power and sample size calculation by nQuery®. References. Appendix. 6 Presentation of bioequivalence studies. 6.1 Introduction. 6.2 Results from a single-dose study. 6.3 Results from a multiple-dose study. 6.4 Conclusions. References. 7 Designs with more than two formulations. 7.1 Introduction. 7.2 Williams designs. 7.3 Example: Dose linearity study. 7.4 Multiplicity. 7.5 Conclusions. References. 8 Analysis of pharmacokinetic interactions. 8.1 Introduction. 8.2 Pharmacokinetic drug-drug interaction studies. 8.3 Pharmacokinetic food-drug interactions. 8.4 Goal posts for drug interaction studies including no effect boundaries. 8.5 Labeling. 8.6 Conclusions. References. 9 Population and individual bioequivalence. 9.1 Introduction. 9.2 Brief history. 9.3 Study designs and

Dieter Hauschke, ALTANA Pharma, Konstanz, Germany.
Well-respected statistician working in the pharmaceutical industry,
specializing in bioequivalence studies, with over 60 publications
in leading journals.

Volker Steinijans, ALTANA Pharma, Konstanz, Germany. Head
of the Department of Biometry and Clinical Data Management at
ALTANA.

Iris Pigeot, Institute for Statistics, University of
Bremen, Germany. Has over 50 published papers, and also written a
number of books in German.

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