Application of preclinical data to initiate the modified continual reassessment method for maximum tolerated dose-finding trials

This study was conducted to evaluate whether the allometric approach can be used to predict maximum tolerated dose (MTD) in humans from animal data. T wenty-five anticancer drugs were taken from the literature and used in this analysis. The results of the study indicate that MTD can be predicted with reasonable accuracy using interspecies scaling. The predicted MTD can then be applied to the modified continual reassessment method retrospectively f or the selection of initial and subsequent doses of anticancer drugs in the patient population. This approach can save time and avoid many unnecessary steps to attain MTD in humans if it could be applied prospectively. Journa l of Clinical Pharmacology, 2001;41:19-24 (C) 2001 the American College of Clinical Pharmacology.