Description

The maximum or maximal tolerated dose is the highest dose of drug that can be given without unacceptable adverse effects.


The concept is related to "dosing to toxicity".

 

Issues in concept:

(1) severity of adverse effects

(2) evidence of benefit at given dose

 

The concept works for a drug which shows a dose-dependent benefit AND the side effects are bothersome but not serious or which can be controlled.

 

The concept does not work if there is no evidence that a higher dose is beneficial OR if the side effects are serious (like bone marrow depression or renal failure).


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