30 Day FDA Drug Development in Ca...
30 Day FDA Drug Development in Cannabinoid and Psychedelic Spaces - Day 28 Putting It All Together – Case Study

Cannabinoid and Psychedelic Pharmacology and Drug Developmen... by Jim Mitchell and Google NotebookLM

Episode notes

This podcast episode explores the development process of bringing a psilocybin product to market using the Quality by Design (QbD) approach. The discussion covers critical quality attributes (CQAs), design of experiments (DOE), impurity testing, method validation, FDA submission requirements, and post-market surveillance. The hosts delve into important considerations like product safety, stability, and purity while also addressing broader societal concerns around accessibility, equity, and responsible use of psychedelic therapeutics.