Pre-clinical drug development_1slide
Pre-clinical drug development_1slide
Pre-clinical drug development_1slide
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NIH Clinical Pharmacology 3-25-10Translational Research TimelinesTarget ID/Valid. NME Ph I/II Ph IIIDrug Development Timeline<strong>Pre</strong>dictive BiomarkersPD/MofA BiomarkersCompanionDiagnostic• Pharmacodynamic/Mechanism of Action Biomarkers– Inform about a <strong>drug</strong>’s pharmacodynamic actions– What is the <strong>drug</strong> doing in the patient and/or tumor?• <strong>Pre</strong>dictive Biomarkers– Optimize patient selection by selecting subpopulations fortreatment– Who should or should not get this <strong>drug</strong>?– Basis for stratified/personalized medicine strategies51
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