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Poor dose optimization of oncology therapies may result in reduced efficacy, greater toxicity, worse adherence, and reduced clinical benefit In phase i trials, data are collected to gather critical information on. This mtd is taken forward into subsequent trials to establish the safety and efficacy of the drug product.
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The pivotal aspect of a phase 1 oncology trial, assessing a new cancer treatment’s safety and dosage, revolves around determining the appropriate dose escalation given the observations of toxicity. Phase i trials define the initial stage of clinical investigation for novel therapeutic agents, designed to evaluate their safety and tolerability profiles while elucidating their pharmacokinetic and pharmacodynamic properties for the first time in humans and, in the case of anticancer agents, in patients with tumors [85] These trials aim to determine the maximum tolerated dose (mtd) of a new drug or therapy
