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Evaluation of Utility of Pharmacokinetic Studies in Phase I Trials of Two Oncology Drugs

Evaluation of Utility of Pharmacokinetic Studies in Phase I Trials of Two Oncology Drugs

Abstract Purpose: There are many phase I trials of oncology drug combinations, very few of which report clinically significant pharmacokinetic interactions. We hypothesized that the utility of such pharmacokinetic drug–drug interaction (DDI) studies is low in the absence of a mechanistic hypothesis. Experimental Design: We retrospectively reviewed 152 phase I …