{"product_id":"9780470094754","title":"Bioequivalence Studies in Drug Development Methods and Applications","description":"\u003ch3\u003eStatistics in Practice\u003c\/h3\u003e\u003ch1\u003eBioequivalence Studies in Drug Development\u003c\/h1\u003e\u003ch2\u003eMethods and Applications\u003c\/h2\u003e\u003ch3\u003eDieter Hauschke | Volker Steinijans | Iris Pigeot\u003c\/h3\u003e\u003cdiv\u003e\u003cb\u003eMedical \/ Biostatistics\u003c\/b\u003e\u003c\/div\u003e\u003cbr\u003e\u003cdiv\u003eStudies 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.  \u003cp\u003e\u003ci\u003eBioequivalence Studies in Drug Development\u003c\/i\u003e 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.\u003c\/p\u003e \u003cul\u003e \u003cli\u003eIncludes all the necessary pharmacokinetic background information.\u003c\/li\u003e \u003cli\u003ePresents parametric and nonparametric statistical techniques.\u003c\/li\u003e \u003cli\u003eDescribes adequate methods for power and sample size determination.\u003c\/li\u003e \u003cli\u003eIncludes appropriate presentation of results from bioequivalence studies.\u003c\/li\u003e \u003cli\u003eProvides a practical overview of the design and analysis of bioequivalence studies.\u003c\/li\u003e \u003cli\u003ePresents the recent developments in methodology, including population and individual bioequivalence.\u003c\/li\u003e \u003cli\u003eReviews the regulatory guidelines for such studies, and the existing global discrepancies.\u003c\/li\u003e \u003cli\u003eDiscusses the designs and analyses of drug-drug and food-drug interaction studies.\u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003e\u003ci\u003eBioequivalence Studies in Drug Development\u003c\/i\u003e 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.\u003c\/p\u003e\n\u003c\/div\u003e\u003cdiv\u003e  \u003cb\u003eDieter Hauschke,\u003c\/b\u003e ALTANA Pharma, Konstanz, Germany. Well-respected statistician working in the pharmaceutical industry, specializing in bioequivalence studies, with over 60 publications in leading journals.  \u003cp\u003e\u003cb\u003eVolker Steinijans,\u003c\/b\u003e ALTANA Pharma, Konstanz, Germany. Head of the Department of Biometry and Clinical Data Management at ALTANA.\u003c\/p\u003e \u003cp\u003e\u003cb\u003eIris Pigeot,\u003c\/b\u003e Institute for Statistics, University of Bremen, Germany. Has over 50 published papers, and also written a number of books in German.\u003c\/p\u003e\n\u003c\/div\u003e\u003cbr\u003e\u003ctable\u003e\n\u003ctr\u003e\n\u003ctd\u003ePublication Date: \u003c\/td\u003e\n\u003ctd\u003e06 March 2007\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003ePublisher: \u003c\/td\u003e\n\u003ctd\u003eWiley\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eImprint: \u003c\/td\u003e\n\u003ctd\u003eWiley\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eISBN-13: \u003c\/td\u003e\n\u003ctd\u003e9780470094754\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eFormat: \u003c\/td\u003e\n\u003ctd\u003eHardback\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003ePage Count: \u003c\/td\u003e\n\u003ctd\u003e336\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eWeight (oz): \u003c\/td\u003e\n\u003ctd\u003e25.0\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/table\u003e","brand":"Wiley","offers":[{"title":"Default Title","offer_id":44379061321868,"sku":"9780470094754","price":111.56,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0710\/9545\/1788\/files\/9780470094754_001fa398-b551-4f52-a81a-0b84a791ba62.jpg?v=1780196462","url":"https:\/\/lateknightbooks.com\/products\/9780470094754","provider":"Late Knight Books and Services, LLC","version":"1.0","type":"link"}