EPISODE · Jan 31, 2025 · 15 MIN
30 Day FDA Drug Development in Cannabinoid and Psychedelic Spaces - Day 3 Phase-Appropriate Drug Development
from Cannabinoid and Psychedelic Pharmacology and Drug Development
This podcast episode explores phase-appropriate drug development, detailing how testing and validation requirements evolve from early to late-stage clinical trials. It covers the progression from Phase 1's initial safety focus and limited process validation to Phase 2's more comprehensive analytical testing and critical process parameters. The discussion emphasizes how Phase 3 requires rigorous process validation and fully validated analytical methods to ensure consistent, large-scale manufacturing. Throughout the episode, special attention is given to synthetic cannabinoids and psychedelics, highlighting the importance of purity and careful control strategies for these potent substances.
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30 Day FDA Drug Development in Cannabinoid and Psychedelic Spaces - Day 3 Phase-Appropriate Drug Development
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