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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

21:19

30 Day FDA and ICH Drug Development Regulations - Day...

Cannabinoid and Psychedelic Pharmacology and Drug... ·

2025/01/29

Uncover the intricate ethical landscape behind every pill in your medicine cabinet. This episode takes you through the unseen journey of drug development, from phase one trials and informed consent to global manufacturing and the delicate balance between safety, access, and equity. Explore how international guidelines, rigorous oversight, and cutting-edge science work together to address impurities, ensure fairness, and protect patient health. A thought-provoking look at the dedication and

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19:16

30 Day FDA and ICH Drug Development Regulations - Day...

Cannabinoid and Psychedelic Pharmacology and Drug... ·

2025/01/29

Dive into the intricate world of global drug development, from groundbreaking ideas in the lab to the medications in your cabinet. Discover how international guidelines, outsourcing partnerships, and advanced technologies like AI are shaping a complex, interconnected system. Uncover the challenges of ethical clinical trials, supply chain risks, and balancing innovation with affordability. Explore the promise of personalized medicine, wearable tech, and real-world data as we look toward a future

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14:27

30 Day FDA and ICH Drug Development Regulations - Day...

Cannabinoid and Psychedelic Pharmacology and Drug... ·

2025/01/29

Explore the fascinating and often hidden world of regulatory submissions, the backbone of bringing new drugs from lab to market. This episode unpacks the journey from investigational new drug applications (INDs) to new drug applications (NDAs) and biologics license applications (BLAs), revealing the intricate processes that ensure safety, efficacy, and quality. Learn about the key elements of these submissions, including clinical trial designs, manufacturing standards, and even the packaging and

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15:51

30 Day FDA and ICH Drug Development Regulations - Day...

Cannabinoid and Psychedelic Pharmacology and Drug... ·

2025/01/29

ICH Q9 and computerized systems are integral to modern drug development, emphasizing risk management, data integrity, and regulatory compliance. ICH Q9 provides a framework to identify, analyze, and control risks throughout the drug development lifecycle. Computerized systems validation ensures these systems are reliable through a process of defining requirements, rigorous testing, and continuous monitoring. Data integrity, a cornerstone of ICH Q9, guarantees accuracy, completeness, and

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17:21

30 Day FDA and ICH Drug Development Regulations - Day...

Cannabinoid and Psychedelic Pharmacology and Drug... ·

2025/01/29

The discussion on ICH guidelines Q10 and Q11 offers a fascinating look into the interplay between foundational pharmaceutical regulations and more advanced frameworks designed to enhance quality systems and drug substance development. While cGMPs provide the essential baseline for safe and effective drug manufacturing, Q10 and Q11 take a proactive approach to quality, focusing on continuous improvement and a deep understanding of the manufacturing process.Key elements like CAPA systems, design

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31:45

30 Day FDA and ICH Drug Development Regulations - Day...

Cannabinoid and Psychedelic Pharmacology and Drug... ·

2025/01/29

The discussion on FDA’s accelerated approval pathways and advancements like gene therapy highlights the dynamic and evolving nature of modern medicine. Accelerated pathways aim to bring treatments for serious conditions, rare diseases, and unmet medical needs to patients more quickly, balancing the urgency of access with the necessity of safety and efficacy. These innovations, such as gene therapy, which targets diseases at their genetic root, offer unprecedented hope for treating and potentially

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13:16

30 Day FDA and ICH Drug Development Regulations - Day...

Cannabinoid and Psychedelic Pharmacology and Drug... ·

2025/01/29

Real-World Evidence (RWE) is reshaping how we understand and improve medications post-approval. In this deep dive, we explored its pivotal role in capturing data from patient records, wearable devices, and insurance claims to uncover hidden safety risks, refine drug efficacy, and even identify unexpected benefits. We discussed how RWE complements stringent regulations like 21 CFR 211 by acting as an early warning system for drug impurities and manufacturing changes, ensuring patient safety.The

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13:16

30 Day FDA and ICH Drug Development Regulations - Day...

Cannabinoid and Psychedelic Pharmacology and Drug... ·

2025/01/29

Real-World Evidence (RWE) is reshaping how we understand and improve medications post-approval. In this deep dive, we explored its pivotal role in capturing data from patient records, wearable devices, and insurance claims to uncover hidden safety risks, refine drug efficacy, and even identify unexpected benefits. We discussed how RWE complements stringent regulations like 21 CFR 211 by acting as an early warning system for drug impurities and manufacturing changes, ensuring patient safety. The

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15:06

30 Day FDA and ICH Drug Development Regulations - Day...

Cannabinoid and Psychedelic Pharmacology and Drug... ·

2025/01/29

Discover the fascinating world of post-marketing surveillance in this episode, where we explore how the journey of a drug continues long after it hits the market. Learn how pharmacovigilance, adverse event reporting, and risk management plans ensure ongoing safety and effectiveness in the real world. Dive into the critical roles of observational studies, Phase IV trials, and groundbreaking laws like PREA that push for pediatric-specific research. Uncover the ethical balance between data collection

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19:44

30 Day FDA and ICH Drug Development Regulations - Day...

Cannabinoid and Psychedelic Pharmacology and Drug... ·

2025/01/29

Dive into the intricate world of biologics and biosimilars in this episode as we unravel the science, regulations, and real-world impact of these groundbreaking therapies. From their unique manufacturing challenges and complex molecular structures to the rigorous clinical trials and approval pathways, we explore what makes biologics the pinnacle of medical innovation. Learn how biosimilars are paving the way for more affordable and accessible treatments, their potential to transform healthcare, and

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24:19

30 Day FDA and ICH Drug Development Regulations - Day...

Cannabinoid and Psychedelic Pharmacology and Drug... ·

2025/01/29

Explore the intricate world of ICH efficacy guidelines in this episode, as we break down the E series—the global rulebook ensuring safe and effective drug development. From selecting meaningful trial endpoints to navigating the complexities of pediatric trials, statistical analyses, and personalized medicine through biomarkers, we uncover how these guidelines shape the future of healthcare. Learn how harmonization fosters collaboration, safeguards patients, and accelerates innovation worldwide,

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22:11

30 Day FDA and ICH Drug Development Regulations - Day...

Cannabinoid and Psychedelic Pharmacology and Drug... ·

2025/01/29

Dive into Day 19 of our deep dive as we explore the fascinating, complex world of nutraceuticals, prescription drugs, and the intricate regulations that govern them. Discover how safety, efficacy, and marketing claims shape the products we use, the rigorous clinical trials that ensure prescription drug reliability, and the persistent battle against impurities in medications. From FDA oversight to the chemistry behind drug stability, this episode unpacks the meticulous processes ensuring the

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18:42

30 Day FDA and ICH Drug Development Regulations - Day...

Cannabinoid and Psychedelic Pharmacology and Drug... ·

2025/01/29

Dive into the fascinating world of GRAS—"Generally Recognized as Safe"—in this eye-opening episode! From decoding the regulatory twists of GRAS to navigating the booming market of natural extracts like cannabinoids and psilocybin, we unpack what "safe" really means in food, drinks, and supplements. Learn to spot red flags, ask the right questions, and make informed choices about the products you consume. Empower yourself with the knowledge to protect your health in a world filled with bold claims

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22:01

30 Day FDA and ICH Drug Development Regulations - Day...

Cannabinoid and Psychedelic Pharmacology and Drug... ·

2025/01/29

Join us as we explore the fascinating world of medications in this episode of Deep Dive! From the rigorous regulations behind prescription drugs to the murky waters of nutraceuticals and the rising interest in CBD, we break down what you need to know to navigate the world of health products. Learn about the pathways that bring drugs to market, the safeguards of clinical trials, and how patients and professionals alike contribute to medical advancements. Empower yourself with the knowledge to make

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26:21

30 Day FDA and ICH Drug Development Regulations - Day...

Cannabinoid and Psychedelic Pharmacology and Drug... ·

2025/01/29

Explore the fascinating world of drug safety with a deep dive into ICH S7 guidelines. Discover how rigorous testing, from animal models to cutting-edge tech like in vitro methods and computer simulations, ensures medications are safe for human use. Learn how researchers assess effects on vital systems like the heart, lungs, and nervous system, and how post-market surveillance continues to protect patients after approval. A compelling look at the science, ethics, and collaboration driving safer, more

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25:05

30 Day FDA and ICH Drug Development Regulations - Day...

Cannabinoid and Psychedelic Pharmacology and Drug... ·

2025/01/29

Dive into the complex world of controlled substances in this episode of Deep Dive. From the meticulous schedules of the Controlled Substances Act to the balancing act between regulation, research, and public safety, we explore how powerful drugs are developed, monitored, and controlled. Learn about the roles of the FDA and DEA, the challenges of manufacturing and distribution, and the growing interest in cannabinoids and psychedelics. We also tackle the vital topics of addiction, harm reduction, and

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15:42

30 Day FDA and ICH Drug Development Regulations - Day...

Cannabinoid and Psychedelic Pharmacology and Drug... ·

2025/01/28

Dive into the world of Current Good Manufacturing Practices (CGMPs), the unsung heroes of pharmaceutical manufacturing. This episode unpacks how meticulous documentation, facility design, quality control, and personnel training ensure the safety and efficacy of medications. Learn about the Master Batch Record, FDA oversight, and the critical role of CDMOs in drug production. We also explore how CGMPs adapt to challenges like biopharmaceuticals, personalized medicine, and global harmonization

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23:36

30 Day FDA and ICH Drug Development Regulations - Day...

Cannabinoid and Psychedelic Pharmacology and Drug... ·

2025/01/28

Mutagenic impurities are a critical concern in pharmaceutical safety, governed by the ICH M7 guidelines. This deep dive explored the complex interplay of science, regulation, and manufacturing processes designed to identify, assess, and control these potentially harmful impurities. Key points included the use of tools like QSAR (Quantitative Structure-Activity Relationship) for predicting the mutagenic potential of impurities based on molecular structure and the calculation of Acceptable Daily

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17:01

30 Day FDA and ICH Drug Development Regulations - Day...

Cannabinoid and Psychedelic Pharmacology and Drug... ·

2025/01/28

This episode takes a closer look at pharmaceutical impurities and the ICH guidelines (Q3A-Q3E) that govern their identification, classification, and control. From organic and inorganic impurities to residual solvents, we explore how these unwanted substances can originate, how they're detected using advanced analytical techniques like mass spectrometry, and how acceptable daily intake (ADI) levels are established to ensure patient safety.We delve into the role of stability testing in managing

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21:41

30 Day FDA and ICH Drug Development Regulations - Day...

Cannabinoid and Psychedelic Pharmacology and Drug... ·

2025/01/28

This episode dives into the world of analytical validation, focusing on the ICH Q2 guidelines and their role in ensuring reliable data in drug development. We break down critical concepts like accuracy, precision, specificity, and robustness, explaining how each contributes to producing safe and effective medications. We also explore why early drug development relies on verification instead of validation and how this process evolves for biologics, tackling challenges like variability and the need

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252 results

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