30 Day FDA Drug Development in Cannabinoid and Psychedelic Spaces - Day 11 Nitrosamine Impurities and Genotoxic Concerns

This podcast episode explores the critical role of impurity assessments in psychedelic drug development, focusing on two major types: nitrosamine and genotoxic impurities. The discussion covers why these impurities are concerning, with nitrosamines being carcinogenic and genotoxic impurities capable of damaging DNA. The episode delves into detection methods, control strategies, and regulatory requirements, particularly highlighting the challenges specific to psychedelic therapeutics due to their chemical structure. Industry experts discuss the importance of proactive risk assessment and the use of advanced analytical techniques to ensure drug safety while navigating the path to market approval.