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Bioequivalence studies in drug development : methods and applications

Author: Dieter Hauschke; Volker Steinijans; Iris Pigeot
Publisher: Chichester, England ; Hoboken, NJ : Wiley, ©2007.
Series: Statistics in practice.
Edition/Format:   eBook : Document : EnglishView all editions and formats
Summary:
"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."--Jacket.
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Genre/Form: Electronic books
Additional Physical Format: Print version:
Hauschke, Dieter.
Bioequivalence studies in drug development.
Chichester, England ; Hoboken, NJ : Wiley, ©2007
(DLC) 2006029953
(OCoLC)71328353
Material Type: Document, Internet resource
Document Type: Internet Resource, Computer File
All Authors / Contributors: Dieter Hauschke; Volker Steinijans; Iris Pigeot
ISBN: 9780470094761 0470094761 0470094753 9780470094754 9780470094778 047009477X
OCLC Number: 128048147
Description: 1 online resource (xi, 311 pages) : illustrations
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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Abstract:

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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