Role of Pharmacogenomics in Drug Development – An Industry ...
Role of Pharmacogenomics in Drug Development – An Industry ...
Role of Pharmacogenomics in Drug Development – An Industry ...
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PGx is happen<strong>in</strong>g now• Rout<strong>in</strong>e DNA collection <strong>in</strong> cl<strong>in</strong>ical trials• Retrospective analysis <strong>of</strong> efficacy and safety<strong>–</strong> Hypothesis generation• Prospective Efficacy PGx and Safety PGx<strong>–</strong> Hypothesis test<strong>in</strong>g<strong>–</strong> Cl<strong>in</strong>ical study design• Applications will be case specific<strong>–</strong> Support <strong>in</strong>ternal decision mak<strong>in</strong>g<strong>–</strong> Support Regulatory approval<strong>–</strong> May not result <strong>in</strong> a PGx test• High <strong>in</strong>terest and engagement from Regulators andHealthcare policymakers
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