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Dosing advice for people with weak kidneys or liver is often missing at approval and added years later, if ever. Requiring those studies before approval would protect a large group of real-world patients from day one.
Regulators require dedicated or population-PK-based organ impairment dosing recommendations (mild, moderate and, where feasible, severe renal and hepatic impairment) as part of the initial marketing application for oncology drugs, rather than as post-marketing commitments, using sparse PK from broadened-eligibility trials and small dedicated cohorts. Ties to relaxing organ-function eligibility criteria.
Shares Older and multimorbid patients are excluded and undertreated, Wrong doses, Trials enrol too few, too slowly, Renal cell carcinoma.
Shares Older and multimorbid patients are excluded and undertreated, Trials enrol too few, too slowly.
Shares Older and multimorbid patients are excluded and undertreated, Wrong doses.
Shares Older and multimorbid patients are excluded and undertreated, Wrong doses.
Shares Older and multimorbid patients are excluded and undertreated, Renal cell carcinoma.
Shares Older and multimorbid patients are excluded and undertreated, Wrong doses.
Shares Wrong doses, Multiple myeloma.