Produktbild: Bioequivalence Studies in Drug Development

Bioequivalence Studies in Drug Development Methods and Applications

Aus der Reihe Statistics in Practice

133,99 €

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Beschreibung

Produktdetails

Einband

Gebundene Ausgabe

Erscheinungsdatum

01.03.2007

Verlag

John Wiley & Sons

Seitenzahl

304

Maße (L/B/H)

25,1/17,4/2,4 cm

Gewicht

709 g

Auflage

1. Auflage

Sprache

Englisch

ISBN

978-0-470-09475-4

Beschreibung

Rezension

"The book provides an excellent introduction for researchers approaching the concept of bioequivalence and is a complete and useful compendium for experienced statisticians." ( Biometrical Journal , April 2009) "The book provides an excellent introduction for researchers approaching the concept of bioequivalence and is a complete and useful compendium for experienced statisticians." ( Biometrical Journal , April 2009) "The book provides an important reference providing many worked examples with real data from drug development. Professionals from the harmaceutical industry and regulatory bodies will particularly appreciate the emphasis made on regulatory guidelines." ( Statistical Methods in Medical Research , February 2009) "I recommend the book as an extensive reference on bioequivalence and as informative reading for a student or professional who is already acquainted with the basics of clinical trials." ( Journal of the Royal Statistical Society , October 2008) "For anyone interested in any aspect of bioequivalence, the book is a very valuable reference." ( International Statistical Review , 2007) " my pleasure to review I would like to add this book to my book collection of pharmaceutical research and development." ( Biometrics , September 2007) " those statisticians working in this area of research will find that this book will serve as a an excellent reference..." ( Journal of Biopharmaceutical S tatistics, Jan 2008)

Produktdetails

Einband

Gebundene Ausgabe

Erscheinungsdatum

01.03.2007

Verlag

John Wiley & Sons

Seitenzahl

304

Maße (L/B/H)

25,1/17,4/2,4 cm

Gewicht

709 g

Auflage

1. Auflage

Sprache

Englisch

ISBN

978-0-470-09475-4

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  • Produktbild: Bioequivalence Studies in Drug Development
  • 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(r).
     
    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 statistical models.
     
    9.4 Population bioequivalence.
     
    9.5 Individual bioequivalence.
     
    9.6 Disaggregate criteria.
     
    9.7 Other approaches.
     
    9.8 Average bioequivalence in replicate designs.
     
    9.9 Example: The anti-hypertensive patch dataset.
     
    9.10 Conclusions.
     
    References.
     

    10 Equivalence assessment in case of clinical endpoints.
     
    10.1 Introduction.
     
    10.2 Design and testing procedure.
     
    10.3 Power and sample size calculation.
     
    10.4 Conclusions.
     
    Apendix.
     
    References.
     
    Index.