Maximizing Drug Formulation For First-In-Human Trials

Formulation decisions made during first-in-human (FIH) trials can have a lasting impact on a drug candidate’s path to approval. Success depends on balancing speed, safety, bioavailability, stability, and manufacturability while ensuring that early-stage choices support later-phase development and commercialization.

This issue explores how integrated formulation development, GMP manufacturing, analytical testing, and clinical operations can accelerate timelines through real-time data sharing and adaptive manufacturing approaches. It also highlights key considerations for dosage form selection, subject safety, regulatory compliance, and scalable production processes. Through practical case studies, readers will see how proactive planning, flexible formulation strategies, and close collaboration between development teams can help overcome common challenges, reduce delays, and support informed decision-making throughout early drug development.

For organizations pursuing FIH studies, these insights offer valuable guidance on optimizing efficiency while maintaining quality and regulatory readiness