Draft Guidance for Industry and Reviewers on Estimating the Safe Starting Dose in Clinical Trials for Therapeutics in Adult Healthy Volunteers; Availability

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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and reviewers entitled "Estimating the Safe Starting Dose in Clinical Trials for Therapeutics in Adult Healthy Volunteers." This draft guidance outlines a common process (algorithm) and terminology for deriving a maximum recommended starting dose for "first in human" clinical trials of new molecular entities in adult healthy volunteers. Described in the guidance is a method for using nonclinical data to select a maximum starting dose in adult humans that is not expected to result in significant toxicity. The goal is to ensure the safety of adult human volunteers in initial clinical trials.