{"product_id":"bioequivalence-studies-in-drug-development-methods-and-applications-hardback-9780470094754","title":"Bioequivalence Studies in Drug Development; Methods and Applications (Hardback) 9780470094754","description":"\u003cfont face=\"Georgia\"\u003e\r\n\u003cp\u003e\u003cfont size=\"6\"\u003eBioequivalence Studies in Drug Development\u003c\/font\u003e\u003cbr\u003e\r\n\u003cfont size=\"5\"\u003eMethods and Applications\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\r\n\r\n\u003cp\u003e\u003cfont size=\"4\"\u003eDieter Hauschke (Author), Volker Steinijans (Author), Iris Pigeot (Author)\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e9780470094754, Wiley\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003eHardback, published 19 January 2007\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e336 pages\u003cbr\u003e22.9 x 15.2 x 2.4 cm, 0.709 kg\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\r\n\u003cp align=\"justify\"\u003e\u003cem\u003e\u003cfont size=\"3\"\u003e\"The book provides an excellent introduction for researchers approaching the concept of bioequivalence and is a complete and useful compendium for experienced statisticians.\" (\u003ci\u003eBiometrical Journal\u003c\/i\u003e, April 2009)  \u003cp\u003e\"The book provides an important reference providing many worked examples with real data from drug development. Professionals from the harmaceutical industry and regulatory bodies will particularly appreciate the emphasis made on regulatory guidelines.\" (\u003ci\u003eStatistical Methods in Medical Research\u003c\/i\u003e, February 2009)\u003c\/p\u003e \u003cp\u003e\"\u003ci\u003eBioequivalence Studies in Drug Development: Methods and Applications\u003c\/i\u003e is an informative, timely, and easy-to-read contribution to bioequivalence and drug-drug\/food-drug interaction literature.\" (\u003ci\u003eJournal of the American Statistical Association\u003c\/i\u003e, September 2008)\u003c\/p\u003e \u003cp\u003e\"…those statisticians working in this area of research will find that this book will serve as an excellent reference for their work...\" (\u003ci\u003eJournal of Biopharmaceutical Statistics\u003c\/i\u003e, January 2008)\u003c\/p\u003e \u003cp\u003e\"This book would be beneficial to both pharmaceutical scientists\/researchers and biostatisticians…\" (\u003ci\u003eBiometrics\u003c\/i\u003e, September 2007)\u003c\/p\u003e \u003cp\u003e\"For anyone interested in any aspect of bioequivalence, the book is a very valuable reference.\" (\u003ci\u003eInternational Statistical Review\u003c\/i\u003e, 2007)\u003c\/p\u003e \u003cp\u003e\"…my pleasure to review…I would like to add this book to my book collection of pharmaceutical research and development.\" (\u003ci\u003eBiometrics\u003c\/i\u003e, September 2007)\u003c\/p\u003e\u003c\/font\u003e\u003c\/em\u003e\u003c\/p\u003e\r\n\r\n\u003cp align=\"justify\"\u003e\u003cstrong\u003e\u003cfont size=\"3\"\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\u003c\/font\u003e\u003c\/strong\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e\u003cb\u003ePreface.\u003c\/b\u003e  \u003cp\u003e\u003cb\u003e1 Introduction.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e1.1 Definitions.\u003c\/p\u003e \u003cp\u003e1.2 When are bioequivalence studies performed.\u003c\/p\u003e \u003cp\u003e1.3 Design and conduct of bioequivalence studies.\u003c\/p\u003e \u003cp\u003e1.4 Aims and structure of the book.\u003c\/p\u003e \u003cp\u003e\u003cb\u003eReferences.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e2 Metrics to characterize concentration-time profiles in single- and multiple-dose bioequivalence studies.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e2.1 Introduction.\u003c\/p\u003e \u003cp\u003e2.2 Pharmacokinetic characteristics (metrics) for single-dose studies.\u003c\/p\u003e \u003cp\u003e2.3 Pharmacokinetic rate and extent characteristics (metrics) for multiple-dose studies.\u003c\/p\u003e \u003cp\u003e2.4 Conclusions.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e3 Basic statistical considerations.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e3.1 Introduction.\u003c\/p\u003e \u003cp\u003e3.2 Additive and multiplicative model.\u003c\/p\u003e \u003cp\u003e3.3 Hypotheses testing.\u003c\/p\u003e \u003cp\u003e3.4 The \u003ci\u003eRT\/TR\u003c\/i\u003e crossover design assuming an additive model.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e4 Assessment of average bioequivalence in the \u003ci\u003eRT\/TR\u003c\/i\u003e design.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e4.1 Introduction.\u003c\/p\u003e \u003cp\u003e4.2 The \u003ci\u003eRT\/TR\u003c\/i\u003e crossover design assuming a multiplicative model.\u003c\/p\u003e \u003cp\u003e4.3 Test procedures for bioequivalence assessment.\u003c\/p\u003e \u003cp\u003e4.4 Conclusions.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e5 Power and sample size determination for testing average bioequivalence in the \u003ci\u003eRT\/TR\u003c\/i\u003e design.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e5.1 Introduction.\u003c\/p\u003e \u003cp\u003e5.2 Challenging the classical approach.\u003c\/p\u003e \u003cp\u003e5.3 Exact power and sample size calculation.\u003c\/p\u003e \u003cp\u003e5.4 Modified acceptance ranges.\u003c\/p\u003e \u003cp\u003e5.5 Approximate formulas for sample size calculation.\u003c\/p\u003e \u003cp\u003e5.6 Exact power and sample size calculation by nQuery®.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003eAppendix.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e6 Presentation of bioequivalence studies.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e6.1 Introduction.\u003c\/p\u003e \u003cp\u003e6.2 Results from a single-dose study.\u003c\/p\u003e \u003cp\u003e6.3 Results from a multiple-dose study.\u003c\/p\u003e \u003cp\u003e6.4 Conclusions.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e7 Designs with more than two formulations.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e7.1 Introduction.\u003c\/p\u003e \u003cp\u003e7.2 Williams designs.\u003c\/p\u003e \u003cp\u003e7.3 Example: Dose linearity study.\u003c\/p\u003e \u003cp\u003e7.4 Multiplicity.\u003c\/p\u003e \u003cp\u003e7.5 Conclusions.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e8 Analysis of pharmacokinetic interactions.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e8.1 Introduction.\u003c\/p\u003e \u003cp\u003e8.2 Pharmacokinetic drug-drug interaction studies.\u003c\/p\u003e \u003cp\u003e8.3 Pharmacokinetic food-drug interactions.\u003c\/p\u003e \u003cp\u003e8.4 Goal posts for drug interaction studies including no effect boundaries.\u003c\/p\u003e \u003cp\u003e8.5 Labeling.\u003c\/p\u003e \u003cp\u003e8.6 Conclusions.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e9 Population and individual bioequivalence.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e9.1 Introduction.\u003c\/p\u003e \u003cp\u003e9.2 Brief history.\u003c\/p\u003e \u003cp\u003e9.3 Study designs and statistical models.\u003c\/p\u003e \u003cp\u003e9.4 Population bioequivalence.\u003c\/p\u003e \u003cp\u003e9.5 Individual bioequivalence.\u003c\/p\u003e \u003cp\u003e9.6 Disaggregate criteria.\u003c\/p\u003e \u003cp\u003e9.7 Other approaches.\u003c\/p\u003e \u003cp\u003e9.8 Average bioequivalence in replicate designs.\u003c\/p\u003e \u003cp\u003e9.9 Example: The anti-hypertensive patch dataset.\u003c\/p\u003e \u003cp\u003e9.10 Conclusions.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e10 Equivalence assessment in case of clinical endpoints.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e10.1 Introduction.\u003c\/p\u003e \u003cp\u003e10.2 Design and testing procedure.\u003c\/p\u003e \u003cp\u003e10.3 Power and sample size calculation.\u003c\/p\u003e \u003cp\u003e10.4 Conclusions.\u003c\/p\u003e \u003cp\u003eApendix.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003e\u003cb\u003eIndex.\u003c\/b\u003e\u003c\/p\u003e\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003eSubject Areas: Mathematics [\u003ca title=\"See our other books on Mathematics\" href=\"https:\/\/freshlyprintedbooks.co.uk\/search?q=%22Mathematics%20%5BPB%5D%22\"\u003ePB\u003c\/a\u003e]\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\u003c\/font\u003e","brand":"Wiley","offers":[{"title":"Brand 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