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Instead of picking the dose by how much patients can tolerate, measure drug levels in blood and relate them to both benefit and harm across patients, then choose the dose that hits the sweet spot.
Registrational packages include population PK and exposure-response analyses for efficacy and the main toxicities, with the target exposure range declared before phase 3 and the chosen dose justified against it; sparse PK sampling in all trial participants makes this feasible. Regulators publish the exposure-response basis for the label dose.
Shares FDA's Project Optimus manifesto: cancer drugs are approved at doses that are too high, Wrong doses.
Shares FDA's Project Optimus manifesto: cancer drugs are approved at doses that are too high, Wrong doses.
Shares FDA's Project Optimus manifesto: cancer drugs are approved at doses that are too high, Wrong doses.
Shares FDA's Project Optimus manifesto: cancer drugs are approved at doses that are too high, Wrong doses.
Shares Pharmacokinetics (PK), half-life and exposure, FDA's Project Optimus manifesto: cancer drugs are approved at doses that are too high.
Shares Regulators beyond the FDA (EMA/CHMP, MHRA, PMDA, NMPA, TGA), Pivotal (registrational) trial.
Shares Regulators beyond the FDA (EMA/CHMP, MHRA, PMDA, NMPA, TGA), Pivotal (registrational) trial.
Shares Pharmacokinetics (PK), half-life and exposure, Wrong doses.