Investigational new drugs
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Investigational new drugs · May 2001
ReviewBody surface area as a determinant of pharmacokinetics and drug dosing.
Body surface area (BSA) was introduced into medical oncology in order to derive a safe starting dose for phase I studies of anticancer drugs from preclinical animal toxicology data. It is not clear however, as to why dosing by BSA was extended to the routine dosing of antineoplastic agents. Several formulas exist to estimate BSA, but the formula derived by DuBois and DuBois is the one used in adult medical oncology. ⋯ Further only epirubicin, etoposide, and carboplatin have been studied to determine if dosing by BSA would reduce interpatient variability, and none of these drugs were found to have significant relationships between their pharmacokinetics and BSA. Future clinical trials of new agents should not presume that dosing based on BSA reduces interpatient variability. Studies should examine the role, if any, BSA has in dosing new chemotherapeutic agents in initial phase I studies.