Pre-clinical drug development_1slide
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Pre-clinical drug development_1slide
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NIH Clinical Pharmacology 3-25-10Non<strong>clinical</strong> QTc Testing Strategy(ICH S7B, 2005)• Routine Non<strong>clinical</strong> Tests– In Vitro I Kr (hERG) assay, and– In vivo QT assay in nonrodent species• May incorporate CV core battery study– Assess chemical/pharmacological class for choice ofreference compounds• Integrated Risk Assessment– Consider all relevant non<strong>clinical</strong> information– Consider follow up studies• Action potential, Rabbit wedge, etc• Determine Evidence of Risk29
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