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Estimating the Maximum Safe Starting Dose for First-in-Human Clinical Trials
The document outlines the process of estimating the maximum safe starting dose (MRSB) for first-in-human clinical trials, emphasizing safety and the importance of determining the no observed adverse effect level (NOAEL) and corresponding human equivalent dose (HED). It details a five-step method for calculating MRSB, considering factors like species differences, safety factors, and pharmacologically active doses. The guidance provided aims to minimize toxicity while ensuring sufficient dosing to achieve trial objectives and includes more conservative alternatives like minimum anticipated biological effect level (MABEL).
