x

75% of people globally want unbiased news (Pew Research) but are concerned they're not getting that.

Get balanced coverage with Symby. See how stories are covered across diverse outlets and spot when one side covers a story the other skips.

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

18:00

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

Cannabinoid and Psychedelic Pharmacology and Drug... ·

2025/01/28

This episode unpacks the fascinating world of Quality by Design (QbD) in drug development, guided by ICH Q8 and Q11 principles. We explore how QbD ensures quality is built into every stage of a drug's lifecycle, from identifying critical quality attributes (CQAs) to defining flexible design spaces for manufacturing.Discover the shift from reactive to proactive approaches in pharmaceutical production, leveraging tools like risk assessment, process modeling, and statistical analysis to optimize

en

14:20

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

Cannabinoid and Psychedelic Pharmacology and Drug... ·

2025/01/28

Today’s episode delves into the complex world of drug product development, breaking down the journey from idea to pharmacy shelf. From formulation design and process validation to stability testing, we explore how every step ensures medications are safe, effective, and consistent.We discuss the importance of regulations like CFR Title 21, covering everything from sanitation to bioequivalence for generic drugs, and how these standards build a foundation of trust and quality. Cutting-edge innovations

en

17:47

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

Cannabinoid and Psychedelic Pharmacology and Drug... ·

2025/01/28

Today’s episode explores the intricate world of ICHQ7, the benchmark for manufacturing active pharmaceutical ingredients (APIs). These guidelines form the backbone of pharmaceutical production, ensuring APIs are made to the highest standards of safety and quality. The discussion highlights the critical role of cleanroom environments, advanced equipment, ongoing personnel training, and exhaustive documentation in maintaining product consistency and preventing contamination. Contract manufacturing

en

20:51

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

Cannabinoid and Psychedelic Pharmacology and Drug... ·

2025/01/28

Welcome back for another deep dive! Today, we’re diving into something that’s at the heart of getting life-changing medications into the hands of patients: the Common Technical Document, or CTD. While it might sound like a dry topic, it’s actually one of the most important tools in the global drug approval process—a true game-changer for both science and public health.Imagine this: you’ve developed a groundbreaking new drug that could change lives. Before it can reach the market, it has to navigate

en

21:32

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

Cannabinoid and Psychedelic Pharmacology and Drug... ·

2025/01/28

In this episode, we take you on a journey through the fascinating world of Good Clinical Practice (GCP) and the ICH E6 guidelines—the gold standard for ethical and scientifically sound clinical research. These aren’t just rules; they’re the foundation of trust and care in drug development, protecting volunteers and ensuring the treatments we rely on are safe and effective.We break down the roles of key players like principal investigators (PIs), sponsors, and contract research organizations (CROs),

en

19:54

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

Cannabinoid and Psychedelic Pharmacology and Drug... ·

2025/01/28

In this episode, we take you on an enlightening journey through the world of clinical trials, exploring how experimental drugs evolve from lab discoveries to life-saving medications in your medicine cabinet. We break down: - The phases of clinical trials: From Phase 1 safety studies with brave volunteers to Phase 3 large-scale trials and ongoing Phase 4 monitoring. - Key study designs: How control groups, randomization, and blinding minimize bias and ensure reliable results. - Innovative

en

19:08

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

Cannabinoid and Psychedelic Pharmacology and Drug... ·

2025/01/28

In this episode, we continue our deep dive into the intricate world of drug development, focusing on the ICH safety guidelines (S-series) that ensure new medicines are thoroughly vetted before they reach the market. From DNA protection to long-term carcinogenicity studies, we uncover how these global standards safeguard patient health while promoting scientific progress. Highlights include: - Genotoxicity and carcinogenicity testing: Evaluating a drug's potential to damage DNA or cause cancer. -

en

19:13

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

Cannabinoid and Psychedelic Pharmacology and Drug... ·

2025/01/28

In this episode, we delve into the fascinating world of pre-clinical drug development—the critical stage where scientists determine whether a drug is safe and effective enough to move to human trials. Often overlooked, this phase lays the groundwork for every new medical breakthrough. We explore: - The rigorous pre-clinical studies, including safety pharmacology, toxicology, PK/PD (pharmacokinetics and pharmacodynamics), and genotoxicity testing. - The role of the Investigational New Drug (IND)

en

15:28

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

Cannabinoid and Psychedelic Pharmacology and Drug... ·

2025/01/28

In today’s episode, we continue our exploration into the intricate world of drug development, this time focusing on the pivotal role of the U.S. Food and Drug Administration (FDA). From preclinical research to post-market surveillance, we unpack how the FDA safeguards public health at every stage of a drug’s journey—from the lab to your medicine cabinet. Join us as we dive into: - The FDA’s mission and structure - Key regulatory pathways like INDs (Investigational New Drug Applications) and NDAs

en

15:05

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

Cannabinoid and Psychedelic Pharmacology and Drug... ·

2025/01/28

In this episode, we take a deep dive into the International Council for Harmonization (ICH) and its vital role in shaping the future of global drug development and regulation. Join us as we explore the collaborative efforts of regulatory authorities and pharmaceutical experts from around the world—including the FDA, EMA, and PMDA—to harmonize guidelines that ensure the safety, quality, and efficacy of medicines.Discover how the ICH streamlines complex regulatory landscapes, adapts to advancements

en

17:42

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

Cannabinoid and Psychedelic Pharmacology and Drug... ·

2025/01/28

Podcast Episode Description🎙️ The Deep Dive: Mapping the Journey of Drug Development 🌍 In this captivating episode of The Deep Dive, we embark on the fascinating and intricate journey of drug development. From the first spark of scientific curiosity in preclinical research to the rigorous clinical trials and ongoing post-market surveillance, we break down the process into approachable, bite-sized insights using a spiral learning approach. Discover the critical roles of the FDA and ICH guidelines

en

35:16

Series Introduction - Structure, Format, and Learning...

Cannabinoid and Psychedelic Pharmacology and Drug... ·

2025/01/28

Join us for an enlightening journey into the fascinating world of pharmacology and drug development in this comprehensive five-season podcast series. In this introduction, we explore the fundamentals of how medications work in our bodies, from the intricate world of cellular receptors to the rigorous processes that ensure drug safety and effectiveness.Using an innovative spiral learning approach, we'll delve into topics including Current Good Manufacturing Practices (CGMP), receptor biology, and the

en

252 results

Similar Podcasts

Classic Radio Science Fiction

solgoodmedia.com

Mission to Mars

Inception Point Ai

The 365 Days of Astronomy

365DaysOfAstronomy.org

Creek Devil

william Jevning

UFO Chronicles Podcast

Nik Hunter