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eBook Bioequivalence Studies in Drug Development: Methods and Applications download
Science
Author: Volker Steinijans,Iris Pigeot,Dieter Hauschke
ISBN: 0470094753
Subcategory: Biological Sciences
Pages 328 pages
Publisher Wiley; 1 edition (February 27, 2007)
Language English
Category: Science
Rating: 4.9
Votes: 253
ePUB size: 1614 kb
FB2 size: 1500 kb
DJVU size: 1840 kb
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eBook Bioequivalence Studies in Drug Development: Methods and Applications download

by Volker Steinijans,Iris Pigeot,Dieter Hauschke


Электронная книга "Bioequivalence Studies in Drug Development: Methods and Applications", Dieter Hauschke, Volker Steinijans, Iris Pigeot

Электронная книга "Bioequivalence Studies in Drug Development: Methods and Applications", Dieter Hauschke, Volker Steinijans, Iris Pigeot. Эту книгу можно прочитать в Google Play Книгах на компьютере, а также на устройствах Android и iOS. Выделяйте текст, добавляйте закладки и делайте заметки, скачав книгу "Bioequivalence Studies in Drug Development: Methods and Applications" для чтения в офлайн-режиме.

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Studies in bioequivalence are the commonly accepted method to demonstrate . Volker Steinijans, ALTANA Pharma, Konstanz, Germany. Has over 50 published papers, and also written a number of books in German.

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. Head of the Department of Biometry and Clinical Data Management at ALTANA. Iris Pigeot, Institute for Statistics, University of Bremen, Germany.

Studies in bioequivalence are the commonly accepted method to demonstrate therapeutic equivalence between two medicinal products

Bioequivalence Studies in Drug Development: Methods and Applications is an informative, timely, and easy-to-read contribution to bioequivalence and drug-drug/food-drug interaction literature. Journal of the American Statistical Association, September 2008). Studies in bioequivalence are the commonly accepted method to demonstrate therapeutic equivalence between two medicinal products. For this reason the design, performance and evaluation of bioequivalence studies have received major attention from academia, the pharmaceutical industry and health authorities

Handle: RePEc:bla:istatr:v:75:y:2007:i:2:p:272-273.

Studies in bioequivalence are the commonly accepted method to demonstrate therapeutic equivalence . Bioequivalence Studies in Drug Development: Methods and Applications is an informative, timely, and easy-to-read contribution to bioequivalence and drug-drug/food-drug interaction literature.

Dieter Hauschke, Volker Steinijans, Iris Pigeot. For this reason the design, performance and evaluation of bioequivalence studies have received major attention from academia, the pharmaceutical industry and health authorities.

Volker Steinijans, Iris Pigeot.

Dieter Hauschke Volker Steinijans Iris Pigeot.

Bioequivalence studies in drug development : methods and applications, Dieter Hauschke, Volker Steinijans, Iris Pigeot. p. ; cm. Includes bibliographical references and indexes. ISBN-13: (HB : alk. paper) ISBN-10: (HB : alk. paper) 1. Drugs Therapeutic equivalency. I. Steinijans, Volker. Dieter Hauschke Volker Steinijans Iris Pigeot. 16. 17 1 Introduction Comparison of therapeutic performance of two medicinal products containing the same active substance is critical for assessing the possibility of supplanting an innovator with any essentially similar medicinal product.

Studies in bioequivalence are the commonly accepted method todemonstrate therapeutic equivalence between two medicinal products.Savings in time and cost are substantial when using bioequivalenceas an established surrogate marker of therapeutic equivalence. Forthis reason the design, performance and evaluation ofbioequivalence studies have received major attention from academia,the pharmaceutical industry and health authorities.

Bioequivalence Studies in Drug Development focuses on theplanning, conducting, analysing and reporting of bioequivalencestudies, covering all aspects required by regulatory authorities.This text presents the required statistical methods, and with anoutstanding practical emphasis, demonstrates their applicationsthrough numerous examples using real data from drugdevelopment.

Includes all the necessary pharmacokinetic backgroundinformation.Presents parametric and nonparametric statisticaltechniques.Describes adequate methods for power and sample sizedetermination.Includes appropriate presentation of results frombioequivalence studies.Provides a practical overview of the design and analysis ofbioequivalence studies.Presents the recent developments in methodology, includingpopulation and individual bioequivalence.Reviews the regulatory guidelines for such studies, and theexisting global discrepancies.Discusses the designs and analyses of drug-drug and food-druginteraction studies.

Bioequivalence Studies in Drug Development is written inan accessible style that makes it ideal for pharmaceuticalscientists, clinical pharmacologists, and medical practitioners, aswell as biometricians working in the pharmaceutical industry. Itwill also be of great value for professionals from regulatorybodies assessing bioequivalence studies.