Dieter Hauschke's Books

Bioequivalence Studies in Drug Development

Methods and Applications

By: Dieter Hauschke,Volker Steinijans,Iris Pigeot

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Bioequivalence Studies in Drug Development

Methods and Applications

By: Dieter Hauschke,Volker Steinijans,Iris Pigeot

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.

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Page Count

328

Publisher

John Wiley & Sons

Published Date

ISBN 10

0470094761

ISBN 13

9780470094761

Triassic Life on Land

The Great Transition

By: Hans-Dieter Sues,Nicholas C. Fraser

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Triassic Life on Land

The Great Transition

By: Hans-Dieter Sues,Nicholas C. Fraser

The Triassic period is generally viewed as the beginning of the Age of Dinosaurs. For paleontologists, however, it also marks the rise of the world's first modern land ecosystems. Over the past three decades, extensive, worldwide fieldwork has led to the discovery of many new species of Triassic animals and plants, suggesting that faunal and floral changes already began in the Middle Triassic and were more protracted than previously thought. The Late Triassic is a pivotal time in the evolution of life on land, with many of the major groups of present-day vertebrates and insects first appearing in the fossil record. This book provides the first detailed overview of life on land during the Triassic period for advanced students and researchers. Noted vertebrate paleontologists Hans-Dieter Sues and Nicholas C. Fraser also review the biotic changes of this period and their possible causes.

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Page Count

249

Publisher

Columbia University Press

Published Date

ISBN 10

0231509413

ISBN 13

9780231509411

Bioequivalence Studies in Drug Development

Methods and Applications

By: Dieter Hauschke,Volker Steinijans,Iris Pigeot

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Bioequivalence Studies in Drug Development

Methods and Applications

By: Dieter Hauschke,Volker Steinijans,Iris Pigeot

Average ratings

N/A

Write a review

Solve jigsaw puzzle

Age

Page Count

328

Publisher

John Wiley & Sons

Published Date

ISBN 10

0470094761

ISBN 13

9780470094761

Book's by Dieter Hauschke

Bioequivalence Studies in Drug Development

Bioequivalence Studies in Drug Development

Triassic Life on Land

Triassic Life on Land

Bioequivalence Studies in Drug Development

Bioequivalence Studies in Drug Development

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