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. Bioequivalence Studies in Drug Development focuses on the planning, conducting, ... Read More
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. 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. Includes all the necessary pharmacokinetic background information. Presents parametric and nonparametric statistical techniques. Describes adequate methods for power and sample size determination. Includes appropriate presentation of results from bioequivalence studies. Provides a practical overview of the design and analysis of bioequivalence studies. Presents the recent developments in methodology, including population and individual bioequivalence. Reviews the regulatory guidelines for such studies, and the existing global discrepancies. Discusses the designs and analyses of drug-drug and food-drug interaction studies. Bioequivalence Studies in Drug Development is written in an accessible style that makes it ideal for pharmaceutical scientists, clinical pharmacologists, and medical practitioners, as well as biometricians working in the pharmaceutical industry. It will also be of great value for professionals from regulatory bodies assessing bioequivalence studies. Read Less
Add this copy of Bioequivalence Studies in Drug Development: Methods and to cart. $82.03, good condition, Sold by Bonita rated 4.0 out of 5 stars, ships from Santa Clarita, CA, UNITED STATES, published 2007 by Wiley.
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PLEASE NOTE, WE DO NOT SHIP TO DENMARK. New Book. Shipped from UK in 4 to 14 days. Established seller since 2000. Please note we cannot offer an expedited shipping service from the UK.
Add this copy of Bioequivalence Studies in Drug Development: Methods and to cart. $120.63, new condition, Sold by Just one more Chapter rated 4.0 out of 5 stars, ships from Miramar, FL, UNITED STATES, published 2007 by Wiley.
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New. 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 provided, so that the book is suitable for both medical practitioners/pharmaceutical scientists, and biometricians. Series: Statistics in Practice. Num Pages: 328 pages, Illustrations. BIC Classification: MMG. Category: (P) Professional & Vocational. Dimension: 249 x 174 x 24. Weight in Grams: 722. 2007. 1st Edition. Hardcover.....We ship daily from our Bookshop.
Add this copy of Bioequivalence Studies in Drug Development: Methods and to cart. $160.81, new condition, Sold by GridFreed rated 5.0 out of 5 stars, ships from San Diego, CA, UNITED STATES, published 2007 by Wiley.
