Bioequivalence Studies in Drug Development: Methods and Applications (Statistics in Practice)
Language: English
Published by Wiley, 2007
- First Edition
- Hardcover
- Used
Seller: killarneybooks, Inagh, Clare, Irelandkillarneybooks
AbeBooks seller since April 20, 2017
Condition: Used - Very good
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Hardcover, xiv + 311 pages, NOT ex-library. Printed in Great Britain. Minor wear, great shape. Book is clean and bright with unmarked text, free of inscriptions and stamps, firmly bound. Issued without a dust jacket. -- This book provides a comprehensive guide to the planning, execution, and statistical evaluation of bioequivalence trials. It begins by establishing the foundational principles, defining bioavailability and therapeutic equivalence, and outlining the regulatory contexts in which these studies are performed for new active substances, approved products, and modified release forms. The text then details the characterization of concentration-time profiles using essential pharmacokinetic metrics for both single and multiple-dose regimens. It builds a robust statistical framework, exploring additive and multiplicative models, normal and lognormal distributions, and the core concepts of hypothesis testing, including consumer and producer risk. A significant focus is placed on the practical assessment of average bioequivalence using the standard RT/TR crossover design, with detailed coverage of analytical procedures such as analysis of variance, the two one-sided t-tests, and nonparametric alternatives. These analytical techniques are logically linked to the crucial planning stages of determining adequate statistical power and sample size, followed by guidance on the proper presentation of results for regulatory submissions. The scope expands to address more complex scenarios, including the use of Williams designs for studies involving more than two formulations, the challenges of multiplicity in dose linearity trials, and the critical analysis of pharmacokinetic interactions like drug-drug and food-drug effects. A distinguishing feature of the work is its in-depth examination of advanced concepts that go beyond simple average comparisons, thoroughly investigating population and individual bioequivalence. This section contrasts aggregate and disaggregate criteria, details the application of replicate designs, and explains moment-based and probability-based statistical procedures. The book's breadth is further demonstrated by extending the principles of equivalence assessment to clinical endpoints, covering methodologies for both parallel group and crossover designs when direct pharmacokinetic surrogates are insufficient.…
Seller Inventory # 012052
- Title
- Bioequivalence Studies in Drug Development: Methods and Applications (Statistics in Practice)
- Author
- Dieter Hauschke; Volker Steinijans; Iris Pigeot
- Publisher
- Wiley
- Publication year
- 2007
- Condition
- Very Good
- Binding
- Hardcover
- Language
- English
- ISBN 10
- 0470094753
- ISBN 13
- 9780470094754
- Edition
- 1st Edition
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.
"Synopsis" may belong to another edition of this title.
About the Author
Volker Steinijans, ALTANA Pharma, Konstanz, Germany. Head of the Department of Biometry and Clinical Data Management at ALTANA.
Iris Pigeot, Institute for Statistics, University of Bremen, Germany. Has over 50 published papers, and also written a number of books in German.
"About the title" may belong to another edition of this title.
killarneybooks
Inagh, Clare, Ireland
AbeBooks seller since April 20, 2017
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All U.S.-bound orders are now shipped with UPS for reliable delivery. Additional customs or import fees are highly unlikely; however, please note buyers remain responsible for any duties or taxes that U.S. Customs may assess. -- Killarneybooks is a family-run bookshop based in the Republic of Ireland. We take pride in accurate listings, careful packaging, and prompt service - most orders ship within 24 hours. All books listed are in stock and ready for immediate dispatch - we are not dropshippers. Inquiries always welcome.…
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