The purpose of First-In-Human (FIH) trials is to study the human pharmacology, pharmacokinetics (PK) and pharmacodynamics (PD), tolerability, and safety of an investigational medicinal product (IMP) having already gone through preclinical studies, and to evaluate how the effects translate from animals to humans. They allow sponsors to determine potential risks associated to the drug at each step of its development and determine the safe dose range in the course of its clinical progression.
In this issue of The Altascientist, we discuss:
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