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Bioequivalence Studies in Drug Development: Methods and Applications

Dieter Hauschke, Volker Steinijans, Iris Pigeot




[PDF.pb88] Bioequivalence Studies in Drug Development: Methods and Applications

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 | #3517883 in Books |  2007-02-27 | Original language:English | PDF # 1 |  9.02 x.95 x5.98l,1.10 | File type: PDF | 328 pages

||2 of 3 people found the following review helpful.| best book on a very important topic|By Michael R. Chernick|As a biostatistician who has written a book on bootstrap methods, been working in the medical device and pharmaceutical industry since 1995 I feel that I am especially qualified to comment on this book. Bioequivalence is a very important topic. When I was at Auxilium Pharmaceuticals Inc., I actually designed an adapti

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 health authorities.

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