March 17, 2025
Regulatory Guidelines for First-in-Human Dosing in Biotech & Pharma
Introduction First-in-human (FIH) dosing represents a critical milestone in the clinical development of new drugs and biologics. This phase is where investigational compounds transition from preclinical studies to human trials, requiring stringent safety protocols. Regulatory guidelines play a fundamental role in ensuring that these trials are conducted with utmost safety, scientific rigor, and ethical considerations….
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