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PODCAST

Cannabinoid and Psychedelic Pharmacology and Drug Development

Jim Mitchell and Google NotebookLM

Explore Cannabinoid and Psychedelic Pharmacology with AI-Powered Learning.Welcome to a groundbreaking approach to mastering cannabinoid and psychedelic pharmacology and the FDA drug development pathway! This podcast series, powered by Google’s Notebook LM, offers a cutting-edge, AI-guided learning experience tailored for formal classes or self-directed study.Each 30-day series delves deep into the science of cannabinoid and psychedelic pharmacology, exploring molecular signaling pathways,

science chemistry

All Episodes

15:41

30 Day FDA Drug Development in Cannabinoid and...

Cannabinoid and Psychedelic Pharmacology and Drug... ·

2025/01/31

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

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19:44

30 Day FDA Drug Development in Cannabinoid and...

Cannabinoid and Psychedelic Pharmacology and Drug... ·

2025/01/31

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)

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15:20

30 Day FDA Drug Development in Cannabinoid and...

Cannabinoid and Psychedelic Pharmacology and Drug... ·

2025/01/31

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

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15:39

30 Day FDA Drug Development in Cannabinoid and...

Cannabinoid and Psychedelic Pharmacology and Drug... ·

2025/01/31

This podcast episode explores Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) in the manufacturing of botanical and psychedelic products. The discussion covers key aspects of product quality including potency, purity, safety, and stability. The episode delves into the complexities of extraction processes, including solvent choice and temperature control, while explaining how design space functions as a framework for ensuring consistent product quality through careful

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20:11

30 Day FDA Drug Development in Cannabinoid and...

Cannabinoid and Psychedelic Pharmacology and Drug... ·

2025/01/31

This podcast episode explores the fundamental differences between synthetic single-molecule compounds and natural extracts in the context of cannabinoids and psychedelics. The discussion delves into the complexities and challenges of working with natural extracts, including concepts like residual complexity, batch variability, cultivar stability, and polypharmacy. The episode then introduces Quality by Design (QBD) as a systematic approach to managing these challenges, explaining how this scientific

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18:08

30 Day FDA Drug Development in Cannabinoid and...

Cannabinoid and Psychedelic Pharmacology and Drug... ·

2025/01/31

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

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15:06

30 Day FDA Drug Development in Cannabinoid and...

Cannabinoid and Psychedelic Pharmacology and Drug... ·

2025/01/31

This podcast episode explores phase-appropriate drug development, detailing how testing and validation requirements evolve from early to late-stage clinical trials. It covers the progression from Phase 1's initial safety focus and limited process validation to Phase 2's more comprehensive analytical testing and critical process parameters. The discussion emphasizes how Phase 3 requires rigorous process validation and fully validated analytical methods to ensure consistent, large-scale manufacturing

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24:20

30 Day FDA Drug Development in Cannabinoid and...

Cannabinoid and Psychedelic Pharmacology and Drug... ·

2025/01/31

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

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14:23

30 Day FDA Drug Development in Cannabinoid and...

Cannabinoid and Psychedelic Pharmacology and Drug... ·

2025/01/31

This podcast episode provides a comprehensive overview of the FDA drug development process for cannabinoid and psychedelic therapeutics. The hosts discuss the journey from pre-clinical research through post-marketing surveillance, explaining key stages including:- Pre-clinical research and molecular interactions with brain receptors- The IND (Investigational New Drug) application process- The three phases of clinical trials and their purposes- Special challenges related to Schedule I substances and

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20:41

30 Day FDA Drug Development in Cannabinoid and...

Cannabinoid and Psychedelic Pharmacology and Drug... ·

2025/01/31

This introductory episode of a 30-day podcast series explores FDA drug development through the lens of cannabis and psychedelic therapeutics. The conversation covers fundamental concepts including cGMP (current good manufacturing practices), ICH guidelines, quality by design, and label accuracy. The hosts emphasize how these regulations ensure drug safety and efficacy while addressing the unique challenges of developing cannabis and psychedelic medicines. The discussion delves into the FDA's role in

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18:48

30 Day Psychedelic Pharmacology Podcast - SPECIAL...

Cannabinoid and Psychedelic Pharmacology and Drug... ·

2025/01/30

This podcast episode discusses the FDA's recent rejection of Lykos's MDMA application for PTSD treatment. The conversation explores the FDA's key concerns, including the need for more long-term data and research on drug interactions. The hosts delve into challenges like designing effective placebo trials, the role of personalized medicine, and the importance of understanding individual variations in treatment response. They also examine safety considerations, ethical concerns, and the future

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25:02

30 Day Psychedelic Pharmacology Podcast - BONUS...

Cannabinoid and Psychedelic Pharmacology and Drug... ·

2025/01/30

This podcast episode offers an in-depth exploration of Alexander Shulgin's life and contributions to psychedelic research. The discussion covers his groundbreaking work in synthesizing and documenting numerous psychedelic compounds, including MDMA and 2C-B. The episode highlights Shulgin's innovative approach to structure-activity relationships (SAR), his meticulous self-experimentation methods, and his collaboration with his wife Ann Shulgin. The conversation delves into specific compounds like DOM

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31:06

30 Day Psychedelic Pharmacology Podcast - Expert...

Cannabinoid and Psychedelic Pharmacology and Drug... ·

2025/01/30

A fascinating and engaging quiz show-style podcast episode about psychedelic pharmacology. The episode features an expert PhD researcher who breaks down complex topics into digestible information, covering key areas such as:- The role of specific receptors like 5HT2A in psychedelic effects- How ketamine affects brain connectivity- The science behind psilocybin's long-lasting effects on neuroplasticity- The future of personalized psychedelic therapies and the ethical considerations in psychedelic

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17:30

30 Day Psychedelic Pharmacology Podcast - Non-Expert...

Cannabinoid and Psychedelic Pharmacology and Drug... ·

2025/01/30

This podcast episode presents an engaging and accessible exploration of psychedelic pharmacology in a quiz show format. The hosts break down complex scientific concepts about how psychedelics interact with the brain, focusing on key topics like receptor binding, neuroplasticity, and therapeutic applications. The discussion covers various substances including psilocybin, ketamine, and MDMA, examining their mechanisms of action and potential therapeutic uses, particularly in treating conditions like

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20:49

30 Day Psychedelic Pharmacology Podcast - Day 30...

Cannabinoid and Psychedelic Pharmacology and Drug... ·

2025/01/30

This podcast episode serves as a thoughtful reflection on a 30-day deep dive into psychedelic pharmacology. The hosts discuss key concepts like receptor pharmacology, comparing psychedelics to keys that fit specific locks in the brain. They explore how different substances like LSD, psilocybin, and MDMA interact with brain receptors, particularly focusing on the important 5HT2A receptor. The conversation also covers therapeutic applications, neuroplasticity, and the crucial role of set and setting

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15:42

30 Day Psychedelic Pharmacology Podcast - Day 29...

Cannabinoid and Psychedelic Pharmacology and Drug... ·

2025/01/30

This podcast episode explores the future of psychedelic therapy, focusing on personalized medicine and innovative delivery methods. Key topics include:- The role of AI in drug discovery and receptor modeling- New delivery methods like transdermal patches and nasal sprays for controlled dosing- The importance of set and setting in therapeutic outcomes- The interaction between MDMA and various serotonin receptors (5HT2A, 5HT2C, and 5HT2B)- The potential of personalized medicine in psychedelic

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22:19

30 Day Psychedelic Pharmacology Podcast - Day 28...

Cannabinoid and Psychedelic Pharmacology and Drug... ·

2025/01/30

This podcast episode explores the legal and regulatory landscape of psychedelic research, covering the historical evolution from the 1950s boom through the restrictive Controlled Substances Act to today's changing environment. The discussion delves into receptor pharmacology, particularly focusing on how 5HT2A receptors influence legal classifications. It also examines promising developments in non-hallucinogenic analogs, MDMA's therapeutic potential for PTSD, and the challenges of implementing

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22:57

30 Day Psychedelic Pharmacology Podcast - Day 27...

Cannabinoid and Psychedelic Pharmacology and Drug... ·

2025/01/30

This podcast episode explores how animal studies help us understand psychedelic effects in humans, with a particular focus on receptor homology and the "lock and key" system of 5HT2A receptors. The discussion covers key research findings about MDMA, including temperature sensitivity and multiple receptor interactions, as well as LSD's effects on brain activity and consciousness. The episode also delves into therapeutic applications, examining how findings from animal studies translate to human

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15:45

30 Day Psychedelic Pharmacology Podcast - Day 26...

Cannabinoid and Psychedelic Pharmacology and Drug... ·

2025/01/30

This podcast episode explores the long-term effects of psychedelics on the brain, discussing key concepts like receptor-mediated neuroplasticity and the importance of set and setting. The conversation covers various substances including MDMA, LSD, and ayahuasca, examining both their therapeutic potential and possible risks. Important topics include:- The role of BDNF in brain plasticity and neural connections- Potential risks like heart valve issues (valvulopathies) with MDMA- The impact on the

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15:09

30 Day Psychedelic Pharmacology Podcast - Day 25...

Cannabinoid and Psychedelic Pharmacology and Drug... ·

2025/01/30

This podcast episode explores the therapeutic potential of psychedelics in oncology, particularly focusing on how substances like psilocybin and MDMA can help cancer patients manage existential distress and improve quality of life. The discussion covers key topics including:- The importance of set and setting in psychedelic therapy- The role of the 5-HT2A receptor in emotional regulation and fear processing- Clinical trials showing promising results in reducing anxiety and depression in cancer

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252 results

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