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Bioequivalence studies in drug development : methods and applications

Author: Dieter Hauschke; Volker Steinijans; Iris Pigeot
Publisher: Chichester, West Sussex, England ; Hoboken, NJ : Wiley, ©2007.
Series: Statistics in practice.
Edition/Format:   Print book : EnglishView all editions and formats
Summary:
Studies in bioequivalence are the commonly accepted method to demonstrate therapeutic equivalence between two medicinal products. Savings in time and cost are substantial when using bioequivalence as an established surrogate marker of therapeutic equivalence. For this reason the design, performance and evaluation of bioequivalence studies have received major attention from academia, the pharmaceutical industry and  Read more...
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Material Type: Internet resource
Document Type: Book, Internet Resource
All Authors / Contributors: Dieter Hauschke; Volker Steinijans; Iris Pigeot
ISBN: 9780470094754 0470094753
OCLC Number: 71328353
Description: xi, 311 pages : illustrations ; 25 cm.
Contents: 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.
Series Title: Statistics in practice.
Responsibility: Dieter Hauschke, Volker Steinijans, Iris Pigeot.
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This book provides an overview of available methods for bioequivalence studies, adopting a practical approach via numerous examples using real data. All medical/pharmacokinetic background is  Read more...

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"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, Read more...

 
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Savings in time and cost are substantial when using bioequivalence as an established surrogate marker of therapeutic equivalence. For this reason the design, performance and evaluation of bioequivalence studies have received major attention from academia, the pharmaceutical industry and health authorities. Bioequivalence Studies in Drug Development focuses on the planning, conducting, analysing and reporting of bioequivalence studies, covering all aspects required by regulatory authorities. This text presents the required statistical methods, and with an outstanding practical emphasis, demonstrates their applications through numerous examples using real data from drug development. Includes all the necessary pharmacokinetic background information. Presents parametric and nonparametric statistical techniques. Describes adequate methods for power and sample size determination. Includes appropriate presentation of results from bioequivalence studies. Provides a practical overview of the design and analysis of bioequivalence studies. Presents the recent developments in methodology, including population and individual bioequivalence. Reviews the regulatory guidelines for such studies, and the existing global discrepancies. 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Content-negotiable representations<\/p>\n