
News|Articles|January 22, 2026
De-Risking FIH: Integrated Strategies for Rapid Proof-of-Concept
Author(s)Quotient Sciences
The transition from preclinical to clinical testing is a pivotal moment in drug development. It’s also one of the most challenging development milestones, beset by unknown risks, unexpected data, and potential regulatory hurdles to overcome. In this article, Quotient Sciences experts discuss how proper planning can avoid missteps in first-in-human studies, looking at trial design, CMC, and regulatory considerations.
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