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Guidance for Industry - Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers

U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER)

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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.
The goals of this guidance are to: (1) establish a consistent terminology for discussing the starting dose; (2) provide common conversion factors for deriving a human equivalent dose (HED); and (3) delineate a strategy for selecting the MRSD for adult healthy volunteers, regardless of the projected clinical use. This process is depicted in a flow chart that presents the decisions and calculations used to generate the MRSD from animal data (see Appendix E).
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

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