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  • Conference proceedings
  • © 2007

Appropriate Dose Selection - How to Optimize Clinical Drug Development

  • Reviews innovative methods, tools and examples of rational drug development strategies, particularly for novel oncological agents
  • Includes supplementary material: sn.pub/extras

Part of the book series: Ernst Schering Foundation Symposium Proceedings (SCHERING FOUND, volume 59)

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Table of contents (16 papers)

  1. Front Matter

    Pages I-XVI
  2. Genotype and Phenotype Relationship in Drug Metabolism

    • I. Roots, G. Laschinski, F. Arjomand-Nahad, J. Kirchheiner, D. Schwarz, J. Brockmöller et al.
    Pages 81-100
  3. Clinical Trials in Elderly Patients

    • S. H. D. Jackson
    Pages 101-109
  4. Dose Finding in Pediatric Patients

    • G. Henze
    Pages 111-121
  5. Ethnic Aspects of Cancer Trials in Asia

    • T. W. T. Leung
    Pages 165-169
  6. Biometrical Aspects of Drug Development

    • D. Machin, S -B. Tan
    Pages 195-207
  7. Back Matter

    Pages 217-221

About this book

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.

Editors and Affiliations

  • Department of Pharmaceutics, School of Pharmacy, Medical College of Virginia, Richmond, USA

    J. Venitz

  • Clinical Pharmacology, Schering AG, Berlin, Germany

    W. Sittner

Bibliographic Information

Buy it now

Buying options

eBook USD 169.00
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book USD 219.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book USD 219.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Other ways to access