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Bioequivalence Studies in Drug Development: Methods and Applications (Statistics in Practice)

by Dieter Hauschke, Volker Steinijans, Iris Pigeot

Publisher: John Wiley & Sons
Publication Date: Friday, March 30, 2007
Number of Pages: 304
ISBN: 0470094753


Book Summary:
There is a real need for a good up-to-date book on the design and analysis of bioequivalence studies and this book fulfills it by providing an overview of available methods, adopting a practical approach via numerous examples using real data. All medical/pharmacokinetic background is provided, so that the book is suitable for both medical practitioners/pharmaceutical scientists, and biometricians. The book includes recent methodology, notably in studies of population and individual bioequivalence, and includes discussion of regulatory issues, and how they differ worldwide.


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Last Updated: 24 November 2007.