Appropriate Dose Selection - How to Optimize Clinical Drug Development
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Beschreibung
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.
Reviews innovative methods, tools and examples of rational drug development strategies, particularly for novel oncological agents Includes supplementary material: sn.pub/extras
Autor*in
J. Venitz
Themen in »Appropriate Dose Selection - How to Optimize Clinical Drug Development«
Biomarkers and Microdosing Optimal Dose Finding Translational Medicine metabolism translation