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This podcast episode explores Quality by Design (QbD) principles in pharmaceutical development, with a special focus on cannabinoid and psychedelic drug manufacturing. The discussion covers the three cornerstone ICH guidelines (Q8, Q9, Q10) and how they enable building quality into medicines from the start rather than just testing final products. The episode delves into practical applications through case studies of companies using QbD for both synthetic compounds and natural extracts, highlighting how advanced technologies like Process Analytical Technology (PAT) and Design of Experiments (DOE) help ensure consistent product quality. The conversation concludes with insights into QbD's role in the future of personalized medicine and 3D-printed drug formulations.
By Jim Mitchell and Google NotebookLMThis podcast episode explores Quality by Design (QbD) principles in pharmaceutical development, with a special focus on cannabinoid and psychedelic drug manufacturing. The discussion covers the three cornerstone ICH guidelines (Q8, Q9, Q10) and how they enable building quality into medicines from the start rather than just testing final products. The episode delves into practical applications through case studies of companies using QbD for both synthetic compounds and natural extracts, highlighting how advanced technologies like Process Analytical Technology (PAT) and Design of Experiments (DOE) help ensure consistent product quality. The conversation concludes with insights into QbD's role in the future of personalized medicine and 3D-printed drug formulations.