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NIH Clinical Pharmacology 3-25-10Nonclinical PK/ADME Studies• Cellular uptake and membrane transport– MDR (P-glycoprotein), MRP, etc.– Predictions of bioavailability and distribution• In vitro drug metabolism– P450 isoenzyme metabolism, inhibition orinduction• Plasma protein binding studies32
NIH Clinical Pharmacology 3-25-10Components of Nonclinical DrugDevelopment• Pharmacology Studies/Model Selection• Safety Pharmacology• PK/ADME Studies• Toxicology• Starting Dose Selection and study designissues for FIH33
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