Cannabinoid and Psychedelic Pharmacology and Drug Development

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...

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...

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...

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 geno...

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 test...

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 blin...

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 invest...

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 co...

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...

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 standar...

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 asse...

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 evolve...

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 ...

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...

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 biopha...

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 psychedeli...

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 compelli...

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...

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 k...