Bioequivalence Studies in Drug Development: Methods and Applications

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9780470094754: Bioequivalence Studies in Drug Development: Methods and Applications
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Studies in bioequivalence are the commonly accepted method todemonstrate therapeutic equivalence between two medicinal products.Savings in time and cost are substantial when using bioequivalenceas an established surrogate marker of therapeutic equivalence. Forthis reason the design, performance and evaluation ofbioequivalence studies have received major attention from academia,the pharmaceutical industry and health authorities.

Bioequivalence Studies in Drug Development focuses on theplanning, conducting, analysing and reporting of bioequivalencestudies, covering all aspects required by regulatory authorities.This text presents the required statistical methods, and with anoutstanding practical emphasis, demonstrates their applicationsthrough numerous examples using real data from drugdevelopment.

  • Includes all the necessary pharmacokinetic backgroundinformation.
  • Presents parametric and nonparametric statisticaltechniques.
  • Describes adequate methods for power and sample sizedetermination.
  • Includes appropriate presentation of results frombioequivalence studies.
  • Provides a practical overview of the design and analysis ofbioequivalence studies.
  • Presents the recent developments in methodology, includingpopulation and individual bioequivalence.
  • Reviews the regulatory guidelines for such studies, and theexisting global discrepancies.
  • Discusses the designs and analyses of drug-drug and food-druginteraction studies.

Bioequivalence Studies in Drug Development is written inan accessible style that makes it ideal for pharmaceuticalscientists, clinical pharmacologists, and medical practitioners, aswell as biometricians working in the pharmaceutical industry. Itwill also be of great value for professionals from regulatorybodies assessing bioequivalence studies.

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About the Author:

Dieter Hauschke, ALTANA Pharma, Konstanz, Germany.Well-respected statistician working in the pharmaceutical industry,specializing in bioequivalence studies, with over 60 publicationsin leading journals.

Volker Steinijans, ALTANA Pharma, Konstanz, Germany. Headof the Department of Biometry and Clinical Data Management atALTANA.

Iris Pigeot, Institute for Statistics, University ofBremen, Germany. Has over 50 published papers, and also written anumber of books in German.

Review:

"The book provides an excellent introduction for researchersapproaching the concept of bioequivalence and is a complete anduseful compendium for experienced statisticians." (BiometricalJournal, April 2009)

"The book provides an important reference providing many workedexamples with real data from drug development. Professionals fromthe harmaceutical industry and regulatory bodies will particularlyappreciate the emphasis made on regulatory guidelines."(Statistical Methods in Medical Research, February 2009)

"Bioequivalence Studies in Drug Development: Methods andApplications is an informative, timely, and easy-to-readcontribution to bioequivalence and drug-drug/food-drug interactionliterature." (Journal of the American StatisticalAssociation, September 2008)

"...those statisticians working in this area of researchwill find that this book will serve as an excellent reference fortheir work..." (Journal of Biopharmaceutical Statistics,January 2008)

"This book would be beneficial to both pharmaceuticalscientists/researchers and biostatisticians..."(Biometrics, September 2007)

"For anyone interested in any aspect of bioequivalence, the bookis a very valuable reference." (International StatisticalReview, 2007)

"...my pleasure to review...I would like to add thisbook to my book collection of pharmaceutical research anddevelopment." (Biometrics, September 2007)

"About this title" may belong to another edition of this title.

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Book Description John Wiley and Sons Ltd, United States, 2007. Hardback. Condition: New. 1. Auflage. Language: English. Brand new Book. 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. Seller Inventory # AAH9780470094754

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Book Description John Wiley and Sons Ltd, United States, 2007. Hardback. Condition: New. 1. Auflage. Language: English. Brand new Book. 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. Seller Inventory # AAH9780470094754

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