Cannabinoid and Psychedelic Pharmacology and Drug Development

Cannabinoid and Psychedelic Pharmacology and Drug Development

by Jim Mitchell and Google NotebookLM
ChemistryLife Sciences
Season 4

30 Day FDA Drug Development in Cannabinoid and Psychedelic Spaces - Day 6 Analytical Method Development and Validation

This podcast episode explores analytical method development and validation in cannabis and psychedelic testing. It breaks down the six key parameters of ICH Q2 guidelines (specificity, accuracy, precision, linearity, range, and robustness) and explains their importance in ensuring product safety and reliability. The discussion covers sophisticated testing techniques like HPLC and mass spectrometry, highlighting how proper testing methods are crucial for accurate labeling, detecting impurities, and maintaining consumer safety. The episode concludes with insights into the future of personalized medicine in cannabis and psychedelics.
S4 · E8
Jan 31, 2025
15:20

30 Day FDA Drug Development in Cannabinoid and Psychedelic Spaces - Day 7 Design of Experiments (D.O.E.) in Process Optimization

This podcast episode explores Design of Experiments (DOE) in pharmaceutical development, particularly focusing on optimizing processes for compounds like dronabinol and psilocybin. The discussion covers three main types of DOE - factorial designs, fractional factorial designs, and response surface methodology (RSM). The episode explains how these methodologies help scientists systematically optimize manufacturing processes while ensuring product quality and safety through Quality by Design (QbD) principles. The experts discuss practical applications, including how DOE helps identify critical process parameters, manage risks, and ensure consistent product quality in pharmaceutical manufacturing.
S4 · E9
Jan 31, 2025
19:44

30 Day FDA Drug Development in Cannabinoid and Psychedelic Spaces - Day 8 Risk Management (ICH Q9) and Subjective Risk Assessments

This podcast episode explores pharmaceutical risk management through ICH Q9 guidelines, focusing on how companies assess and mitigate risks in drug development. The discussion covers key risk assessment tools like Failure Mode and Effects Analysis (FMEA) and Fault Tree Analysis (FTA). Special attention is given to the unique challenges of managing risks in botanical pharmaceuticals like psilocybin and cannabis. The episode also examines how Quality by Design (QbD) principles integrate with risk management to create more robust manufacturing processes. It concludes by discussing emerging trends, including the role of AI in risk assessment and the shift toward personalized medicine.
S4 · E10
Jan 31, 2025
15:41

30 Day FDA Drug Development in Cannabinoid and Psychedelic Spaces - Day 9 Stability Testing and Shelf-Life Determination

This podcast episode explores the science of stability testing and shelf-life determination for sensitive compounds derived from plants and fungi. The discussion covers two main testing approaches - real-time and accelerated testing- and delves into the complexities of working with multiple active compounds like cannabinoids and fungal metabolites. The episode emphasizes the critical importance of accurate stability testing for consumer safety and product labeling, discussing how compounds can degrade over time and even become more potent in some cases. The conversation also touches on the ICH Q1 guidelines as the pharmaceutical industry standard for quality, safety, and efficacy testing.
S4 · E11
Jan 31, 2025
23:57

30 Day FDA Drug Development in Cannabinoid and Psychedelic Spaces - Day 10 Control of Impurities (Organic, Inorganic, Residual Solvents)

This deep-dive podcast episode explores the critical world of drug impurities and their impact on pharmaceutical safety. The discussion covers the ICH guidelines (Q3A through Q3E) that govern impurity control, sophisticated analytical techniques for detection, and real-world applications in both traditional pharmaceuticals and emerging substances like cannabis and psilocybin. The episode breaks down complex concepts like purge factors, nitrosamine impurities, and hyphenated analytical techniques, while emphasizing the importance of quality control in ensuring safe, effective medications.
S4 · E12
Jan 31, 2025
25:10

30 Day FDA Drug Development in Cannabinoid and Psychedelic Spaces - Day 10 Control of Impurities (Organic, Inorganic, Residual Solvents) SUPPLEMENT

This podcast episode explores the fascinating differences between natural botanical extracts and their synthetic counterparts, with a focus on impurities. It delves into how the endocannabinoid system (ECS) interacts with these compounds and introduces the concept of polypharmacy - where multiple compounds work together synergistically. The discussion covers important aspects like variability in natural products, standardization challenges, and safety considerations, while highlighting how these "impurities" might actually be beneficial components that contribute to the overall therapeutic effects.
S4 · E13
Jan 31, 2025
18:31

30 Day FDA Drug Development in Cannabinoid and Psychedelic Spaces - Day 11 Nitrosamine Impurities and Genotoxic Concerns

This podcast episode explores the critical role of impurity assessments in psychedelic drug development, focusing on two major types: nitrosamine and genotoxic impurities. The discussion covers why these impurities are concerning, with nitrosamines being carcinogenic and genotoxic impurities capable of damaging DNA. The episode delves into detection methods, control strategies, and regulatory requirements, particularly highlighting the challenges specific to psychedelic therapeutics due to their chemical structure. Industry experts discuss the importance of proactive risk assessment and the use of advanced analytical techniques to ensure drug safety while navigating the path to market approval.
S4 · E14
Jan 31, 2025
33:42

30 Day FDA Drug Development in Cannabinoid and Psychedelic Spaces - Day 12 Phase-Appropriate Validation vs. Verification

This podcast episode explores the critical differences between validation and verification in analytical methods, particularly for botanical and fungal products. The discussion covers how validation requirements evolve through different phases of product development, from initial testing to commercial production. Key topics include dealing with natural variability in botanical materials, the importance of robust analytical methods, and how these principles apply to both traditional products and emerging fields like psychedelics. The episode also delves into the challenges of managing mutagenic impurities and implementing appropriate control strategies.
S4 · E15
Jan 31, 2025
30:19

30 Day FDA Drug Development in Cannabinoid and Psychedelic Spaces - Day 13 cGMP Fundamentals and Their Societal Impact

This podcast episode explores the fundamentals of Current Good Manufacturing Practices (cGMP) in pharmaceutical production, with a special focus on emerging cannabinoid and psychedelic therapies. The discussion covers key aspects of cGMP including documentation, quality control, facility standards, and personnel training. The episode delves into historical examples like the thalidomide tragedy to illustrate why strict manufacturing standards are crucial. It also addresses current challenges in maintaining product safety, including the management of impurities and the importance of third-party testing. The conversation emphasizes how cGMP helps build trust in new therapeutic areas while ensuring consistent product quality and safety.
S4 · E16
Jan 31, 2025
22:10

30 Day FDA Drug Development in Cannabinoid and Psychedelic Spaces - Day 14 Botanical Drug Development Guidance (FDA)

This episode explores the complexities of botanical drug development, focusing on cannabis and psychedelic mushrooms. The discussion covers key quality control challenges, including the variability of active compounds in natural products and the importance of standardization. The episode explains crucial regulatory frameworks like the Botanical Drug Master File (BDMF) and ICHM7 guidelines, which ensure product safety and consistency. It also delves into extraction methods, purification processes, and the importance of accurate labeling for consumer safety. The conversation emphasizes the role of third-party testing and quality certifications in maintaining product integrity and building consumer trust.
S4 · E17
Jan 31, 2025
16:33
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