Bioequivalence Studies in Drug Development: Methods and Applications - Rilegato

Hauschke, Dieter; Steinijans, Volker; Pigeot, Iris

 
9780470094754: Bioequivalence Studies in Drug Development: Methods and Applications
Rilegato
ISBN 10: 0470094753 ISBN 13: 9780470094754
Casa editrice: John Wiley & Sons Inc, 2007

Sinossi

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.

Le informazioni nella sezione "Riassunto" possono far riferimento a edizioni diverse di questo titolo.

Informazioni sull?autore

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.

Dalla quarta di copertina

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.

Le informazioni nella sezione "Su questo libro" possono far riferimento a edizioni diverse di questo titolo.

Editore
John Wiley & Sons Inc
Data di pubblicazione
2007
Lingua
Inglese
ISBN 10 
0470094753
ISBN 13 
9780470094754
Rilegatura
Copertina rigida
Numero di pagine
311
Contatto del produttore
non disponibile
Persona responsabile
non disponibile