The success of any new drug development starts in its early phase. The probability of success of a molecule increases dramatically after it passes first-in-human (FIH) and proof-of-concept (POC) studies. Building a comprehensive understanding of the molecule is crucial to successful early phase development. API salt form and formulation selections are also key factors to successful phase I studies. Effective CMC strategies can significantly enhance the speed of early phase development and ultimately the chance for success in late-stage development. This webinar will present our experience in using the integrated API and drug product platform and formulation technologies to accelerate early-phase development to phase I and beyond.
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In this webinar, we will discuss the importance of phase-appropriate process development and various
