Bioequivalence studies in drug development [electronic resource] : methods and applications / Dieter Hauschke, Volker Steinijans, Iris Pigeot.

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Bibliographic Details
Online Access: Full Text (via Wiley)
Main Author: Hauschke, Dieter
Other Authors: Steinijans, Volker, Pigeot, Iris
Format: Electronic eBook
Language:English
Published: Chichester, England ; Hoboken, NJ : Wiley, ©2007.
Series:Statistics in practice.
Subjects:

MARC

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245 1 0 |a Bioequivalence studies in drug development  |h [electronic resource] :  |b methods and applications /  |c Dieter Hauschke, Volker Steinijans, Iris Pigeot. 
260 |a Chichester, England ;  |a Hoboken, NJ :  |b Wiley,  |c ©2007. 
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505 0 |a 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. 
520 1 |a "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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