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30 Day FDA Drug Development in Cannabinoid and Psychedelic Spaces - Day 2 Introduction to ICH Guidelines
This podcast episode provides a comprehensive overview of ICH (International Council for Harmonization) guidelines and their application to cannabinoid and psychedelic drug development. The discussion covers the fundamental aspects of ICH guidelines, including:
- The Q series focusing on Good Manufacturing Practices (GMP) and quality control
- Safety (S) and Efficacy (E) modules for ensuring drug safety and effectiveness through clinical trials
- Special challenges in applying these guidelines to cannabinoids and psychedelics, including plant material variability and historical stigma
The episode emphasizes how these guidelines help standardize pharmaceutical development globally while ensuring patient safety and product consistency.
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By Jim Mitchell and Google NotebookLMThis podcast episode provides a comprehensive overview of ICH (International Council for Harmonization) guidelines and their application to cannabinoid and psychedelic drug development. The discussion covers the fundamental aspects of ICH guidelines, including:
- The Q series focusing on Good Manufacturing Practices (GMP) and quality control
- Safety (S) and Efficacy (E) modules for ensuring drug safety and effectiveness through clinical trials
- Special challenges in applying these guidelines to cannabinoids and psychedelics, including plant material variability and historical stigma
The episode emphasizes how these guidelines help standardize pharmaceutical development globally while ensuring patient safety and product consistency.