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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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