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30 Day FDA Drug Development in Cannabinoid and Psychedelic Spaces - Day 28 Putting It All Together – Case Study
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.
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By Jim Mitchell and Google NotebookLMThis 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.