ENGLISH

Appropriate Dose Selection — How to Optimize Clinical Drug Development

By J. Venitz , T. Singer (auth.) , W. Sittner (eds.)

Book information

Publisher
Springer-Verlag Berlin Heidelberg
Year
2007
ISBN
978-3-540-27867-2, 978-3-540-49529-1
DOI
10.1007/978-3-540-49529-1
Language
english
Format
PDF
Filesize
2 MB (1787596 bytes)
Series
Ernst Schering Research Foundation Workshop 59
Edition
1
Pages
216\223
Orientation
yes
Scanned
yes
Time added
2013-08-01 04:00:00
generalgeneral; BiochemistryPharmacology/Toxicology; Medicine/Public Health

Description

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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