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Optimal biological dose: A systematic review in cancer phase I clinical trials

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Classical phase 1 dose-finding designs based on a single toxicity endpoint to assess the maximum tolerated dose were initially developed in the context of cytotoxic drugs. With the emergence of molecular targeted agents and immunotherapies, the concept of optimal biological dose (OBD) was subsequently introduced to account for efficacy in addition to toxicity.
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Optimal biological dose: A systematic review in cancer phase I clinical trials