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Publications internationales
Guidance for Industry - Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers
Guidance for Industry - Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy VolunteersU.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER)Revue :This guidance outlines a process (algorithm) and vocabulary for deriving the maximum recommended starting dose (MRSD) for first-in-human clinical trials of new molecular entities in adult healthy volunteers, and recommends a standardized process by which the MRSD can be selected. The purpose of this process is to ensure the safety of the human volunteers.
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