Bioequivalence Studies in Drug Development: Methods and Applications (Statistics in Practice)

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9780470094754: Bioequivalence Studies in Drug Development: Methods and Applications (Statistics in Practice)
Review:

"The book provides an excellent introduction for researchers approaching the concept of bioequivalence and is a complete and useful compendium for experienced statisticians." (Biometrical Journal, April 2009) "The book provides an excellent introduction for researchers approaching the concept of bioequivalence and is a complete and useful compendium for experienced statisticians." (Biometrical Journal, April 2009) "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." (Statistical Methods in Medical Research, February 2009) "I recommend the book as an extensive reference on bioequivalence and as informative reading for a student or professional who is already acquainted with the basics of clinical trials." (Journal of the Royal Statistical Society, October 2008) "For anyone interested in any aspect of bioequivalence, the book is a very valuable reference." (International Statistical Review, 2007) "...my pleasure to review...I would like to add this book to my book collection of pharmaceutical research and development." (Biometrics, September 2007) "...those statisticians working in this area of research will find that this book will serve as a an excellent reference..." (Journal of Biopharmaceutical Statistics, Jan 2008)

From the Publisher:

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.

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Hauschke, Dieter; Steinijans, Volker; Pigeot, Iris
Editorial: John Wiley and Sons Ltd, United States (2007)
ISBN 10: 0470094753 ISBN 13: 9780470094754
Nuevos Tapa dura Primera edición Cantidad: 1
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Descripción John Wiley and Sons Ltd, United States, 2007. Hardback. Estado de conservación: New. 1. Auflage. 248 x 172 mm. 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. Nº de ref. de la librería AAH9780470094754

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Hauschke, Dieter; Steinijans, Volker; Pigeot, Iris
Editorial: John Wiley and Sons Ltd, United States (2007)
ISBN 10: 0470094753 ISBN 13: 9780470094754
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Descripción John Wiley and Sons Ltd, United States, 2007. Hardback. Estado de conservación: New. 1. Auflage. 248 x 172 mm. 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. Nº de ref. de la librería AAH9780470094754

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Descripción 2007. Hardcover. Estado de conservación: New. 1st. 174mm x 24mm x 251mm. Hardcover. 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 bioequ.Shipping may be from multiple locations in the US or from the UK, depending on stock availability. 311 pages. 0.757. Nº de ref. de la librería 9780470094754

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