Hoppa till sidans huvudinnehåll

Del 47

Bioequivalence Studies in Drug Development

Methods and Applications

Inbunden, Engelska, 2007

AvDieter Hauschke,Volker Steinijans,Iris Pigeot,Germany) Hauschke, Dieter (ALTANA Pharma,Germany) Steinijans, Volker (ALTANA Pharma,Germany) Pigeot, Iris (University of Bremen

1 589 kr

Beställningsvara. Skickas inom 7-10 vardagar. Fri frakt för medlemmar vid köp för minst 249 kr.


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.

Produktinformation

  • Utgivningsdatum2007-01-19
  • Mått152 x 229 x 24 mm
  • Vikt709 g
  • FormatInbunden
  • SpråkEngelska
  • SerieStatistics in Practice
  • Antal sidor336
  • FörlagJohn Wiley & Sons Inc
  • ISBN9780470094754
Hoppa över listan

Mer från samma serie

Del 82

Statistical Practice in Business and Industry

Shirley Coleman, Tony Greenfield, Dave Stewardson, Douglas C. Montgomery, UK) Coleman, Shirley (University of Newcastle, UK) Greenfield, Tony (Greenfield Research, UK) Stewardson, Dave (University of Newcastle, Douglas C. (Arizona State University) Montgomery, Douglas C Montgomery

Inbunden

1 629 kr

Bayesian Biostatistics

Emmanuel Lesaffre, Andrew B. Lawson, Belgium) Lesaffre, Emmanuel (The Netherlands & K.U. Leuven, Leuven, USA) Lawson, Andrew B. (Medical University of South Carolina, Andrew B Lawson

Inbunden

999 kr

Del 35

Uncertain Judgements

Anthony O'Hagan, Caitlin E. Buck, Alireza Daneshkhah, J. Richard Eiser, Paul H. Garthwaite, David J. Jenkinson, Jeremy E. Oakley, Tim Rakow, O Hagan, Caitlin E Buck, J Richard Eiser, Paul H Garthwaite, David J Jenkinson, Jeremy E Oakley

Inbunden

1 079 kr

Hoppa över listan

Du kanske också är intresserad av

Digital Public Health

Hajo Zeeb, Laura Maaß, Tanja Schultz, Ulrike Haug, Iris Pigeot, Benjamin Schüz, Benjamin Schuz

Inbunden

719 kr