Exposure-response modelling with a pre-set target exposure before any dose is chosen
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 key 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.
- Wrong doses · Most drug doses were chosen as the highest a person can tolerate, which is often more than they need.
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