“Where do I start?”: Strategies for selecting the first dose for human clinical trials Dr. Darren Bentley, Senior Director, Integrated Drug Development2 The principal goal of dose selection should always be to safeguard the wellbeing of the study participants. “ “ Technical Guidelines for Drug Interaction Studies A blank page can be daunting. 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 st

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