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Measuring metabolites in index clinical DDI studies

A key drug development safety consideration is whether the drug candidate will interact with co-medications. Drug-drug interaction (DDI) studies are used to help assess this risk. These studies quantify the impact of the drug candidate on key drug-metabolizing enzymes. The most studied metabolic enzymes are the cytochrome P450 (CYP) enzyme family members. Recommended index substrates … Continued

Impact of using time-averaged exposure metrics on binary endpoints in exposure-response analyses

This Frontiers in Pharmacology article investigates how using different time-averaged exposure metrics, specifically the time-averaged concentration to event (CavTE), impacts exposure-response (ER) analyses, particularly when using logistic regression with binary endpoints in drug development. ER analyses are crucial in determining the optimal drug dose that balances efficacy and safety. The study focuses on how CavTE, … Continued

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