Bioequivalence Studies in Drug Development Methods and Applications
Aus der Reihe
Statistics in Practice
94,99 €
inkl. gesetzl. MwSt.Beschreibung
Produktdetails
Format
Kopierschutz
Ja
Family Sharing
Nein
Text-to-Speech
Nein
Erscheinungsdatum
13.03.2007
Verlag
PolitySeitenzahl
328 (Printausgabe)
Dateigröße
19073 KB
Auflage
1. Auflage
Sprache
Englisch
EAN
9780470094761
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.
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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