Knowing where to start is always a challenge, and selecting the initial dose of an investigational drug to be administered in the first clinical study in humans is no exception. Getting it wrong could endanger the lives of the people participating in the study, as well as potentially derailing the whole development program and ruining years of work. The principal goal of dose selection should always be to safeguard the wellbeing of the study participants, often described as picking a “safe” starting dose. However, “safe” should not be interpreted as zero risk, but rather that the level of risk is appropriate and the overall benefit:risk assessment is favorable. A robust dose selection strategy therefore requires a quantitative approach.
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