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Biosimulation in Drug Development

Authors: Martin Bertau, Erik Mosekilde, Hans V. Westerhoff Publisher: Wiley Publication date: 2008 Publication language: Angielski Number of pages: 542 Publication formats: EAN: 9783527622689 ISBN: 9783527622689 Category: Chemistry Biology, life sciences Publisher's index: - Bibliographic note: -

Description

This first comprehensive survey to cover all pharmaceutically relevant topics provides a comprehensive introduction to this novel and revolutionary tool, presenting both concepts and application examples of biosimulated cells, organs and organisms.
Following an introduction to the role of biosimulation in drug development, the authors go on to discuss the simulation of cells and tissues, as well as simulating drug action and effect. A further section is devoted to simulating networks and populations, and the whole is rounded off by a look at the potential for biosimulation in industrial drug development and for regulatory decisions.
Part of the authors are members of the BioSim Network of Excellence that encompasses more than 40 academic institutions, pharmaceutical companies and regulatory authorities dealing with drug development; other contributors come from industry, resulting in a cross-disciplinary expert reference.

TOC

  • Biosimulation in Drug Development 4
    • Contents 8
    • Preface 20
    • List of Contributors 26
    • Part I Introduction 32
      • 1 Simulation in Clinical Drug Development 34
        • 1.1 Introduction 34
        • 1.2 Models for Simulations 38
        • 1.3 Simulations in Clinical Drug Development: Practical Examples 39
          • 1.3.1 Predicting the Outcome of Phase I Studies of Erythropoietin Receptor Agonists 39
          • 1.3.2 Simulations for Antimicrobial Dose Selection 41
          • 1.3.3 Optimizing the Design of Phase II Dose Finding Studies 45
          • 1.3.4 Predicting the Outcome of Phase III Trials Using Phase II Data 50
        • 1.4 Conclusions 54
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