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Translational Science
Translational science bridges preclinical research and clinical development by linking biological mechanisms to clinical outcomes. Translational approaches help inform dose selection, biomarker strategy, and early clinical study design.
Effective translational science integrates data from nonclinical models, clinical observations, and emerging biomarkers to guide development decisions. This approach supports more informed hypothesis testing and reduces uncertainty during early clinical phases.
Translational strategies are particularly valuable in early development and first-in-human programs.
Translational science activities often include:
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Mechanism-of-action evaluation
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Biomarker strategy development
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Dose and exposure–response assessment
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Integration of preclinical and clinical data
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Support for early clinical development planning