Appropriate Dose Selection — How to Optimize Clinical Drug Development

  • J. Venitz
  • W. Sittner

Part of the Ernst Schering Research Foundation Workshop book series (SCHERING FOUND, volume 59)

Table of contents

  1. Front Matter
    Pages I-XVI
  2. I. Roots, G. Laschinski, F. Arjomand-Nahad, J. Kirchheiner, D. Schwarz, J. Brockmöller et al.
    Pages 81-100
  3. S. H. D. Jackson
    Pages 101-109
  4. G. Henze
    Pages 111-121
  5. T. W. T. Leung
    Pages 165-169
  6. D. Machin, S -B. Tan
    Pages 195-207
  7. Back Matter
    Pages 217-221

About these proceedings

Introduction

Optimal dose individualization has become more important in improving clinical efficacy and safety, given the variability in drug response, e.g., due to concurrent illnesses or co-medications. Therefore, the role of optimal dose finding in early clinical drug development so as to maximize successful clinical use is emphasized. The continued use of biomarkers – based on the (known) pharmacology of the drug and/or biology of the underlying disease – along with exposure–response evaluation throughout all phases of drug development can quantitatively integrate clinical pharmacology knowledge, provide early proof of concept, and help in rational dose selection and rational drug product labeling for clinical use.

Keywords

Biomarkers and Microdosing Optimal Dose Finding Translational Medicine metabolism translation

Editors and affiliations

  • J. Venitz
    • 1
  • W. Sittner
    • 2
  1. 1.Department of Pharmaceutics, School of PharmacyMedical College of VirginiaRichmondUSA
  2. 2.Clinical PharmacologySchering AGBerlinGermany

Bibliographic information

  • DOI https://doi.org/10.1007/978-3-540-49529-1
  • Copyright Information Springer-Verlag Berlin Heidelberg 2007
  • Publisher Name Springer, Berlin, Heidelberg
  • eBook Packages Biomedical and Life Sciences
  • Print ISBN 978-3-540-27867-2
  • Online ISBN 978-3-540-49529-1
  • Series Print ISSN 0947-6075
  • About this book