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Appropriate Dose Selection - How to Optimize Clinical Drug Development by J. Venitz

Appropriate Dose Selection - How to Optimize Clinical Drug Development

by J. Venitz
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Book cover type: Paperback
  • ISBN13: 9783642421761
  • Binding: Paperback
  • Subject: N/A
  • Publisher: Springer
  • Publisher Imprint: Springer
  • Publication Date:
  • Pages: 216
  • Original Price: EUR 199.99
  • Language: English
  • Edition: 2007
  • Item Weight: 288 grams
  • BISAC Subject(s): Pharmacology and Life Sciences / Biochemistry

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.

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