Dieter Hauschke, Volker Steinijans, Iris Pigeot

eBook, PDF

Bioequivalence Studies in Drug Development (eBook, PDF)

Methods and Applications

Beschreibung

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.

Technische Details

• Geräte: PC
• mit Kopierschutz
• Größe: 18.63MB

Barrierefreiheit

• Text-to-Speech

Autor

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

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.

Produktdetails

• Verlag: John Wiley & Sons
• Erscheinungstermin: 13. März 2007
• Englisch
• ISBN-13: 9780470094761
• Artikelnr.: 37290443

Rezensionen

"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 S tatistics, Jan 2008)