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PODCAST

From Concept to Medicine - A Comprehensive Drug Development Journey

Welcome to a Complete Drug Development Journey!Have you ever wondered how groundbreaking medicines go from a scientist’s vision to life-saving treatments in hospitals and pharmacies worldwide? The journey of drug development is an intricate, high-stakes adventure—filled with scientific breakthroughs, regulatory twists, and the relentless pursuit of innovation.In this podcast, we take you behind the scenes of pharmaceutical research and development, unraveling the complex and fascinating process that

science chemistry

All Episodes

12:52

110 – Adverse Event Reporting Explained (S8E5)

From Concept to Medicine - A Comprehensive Drug... ·

2025/05/04

This episode provides a detailed explanation of adverse event reporting, covering how these events are identified, reported, and analyzed. We explore systems like FAERS (FDA Adverse Event Reporting System) and discuss regulatory requirements, reporting processes, and industry responsibilities. The discussion highlights the importance of accurate and detailed reporting in ensuring drug safety.The conversation also delves into real-world examples of high-profile adverse events, their impact, and how

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16:16

109 – Post-Marketing Surveillance (S8E4)

From Concept to Medicine - A Comprehensive Drug... ·

2025/05/04

This episode explores the systems and methods used for tracking a drug's real-world performance after it has been approved and is available to patients. We discuss key data sources such as registries, electronic health records, and insurance claims databases. The episode highlights the importance of post-marketing surveillance (PMS) in understanding how a drug behaves in a diverse population, outside the controlled environment of clinical trials.We delve into various analytical approaches used to

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26:12

108 – Role of Pharmacovigilance (S8E3)

From Concept to Medicine - A Comprehensive Drug... ·

2025/05/04

This episode defines pharmacovigilance and explains its critical role in monitoring drug safety after a medication has been approved and is on the market. We delve into the core activities of pharmacovigilance, which include adverse event detection, assessment, understanding, and prevention. The conversation highlights the ongoing nature of safety monitoring, emphasizing that it doesn't end with a drug's approval.Real-world case examples are used to illustrate how potential safety concerns are

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28:07

107 – FDA & ICH Guidelines Overview (S8E2)

From Concept to Medicine - A Comprehensive Drug... ·

2025/05/04

This episode provides a comprehensive overview of the major guidelines from the FDA (Food and Drug Administration) and the ICH (International Council for Harmonization) that shape drug development. The primary focus is on understanding the core principles of safety and quality, and how these are practically implemented in research and development (R&D). This episode covers relevant sections of 12CFR and ICH modules to explore specific requirements. The episode is design to demystify complex

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14:46

106 – Deep Dive into Regulatory Affairs (S8E1)

From Concept to Medicine - A Comprehensive Drug... ·

2025/05/04

This episode introduces the complex world of regulatory affairs within the pharmaceutical industry. We explore the essential framework governing drug development, highlighting key agencies like the FDA (US), EMA (Europe), and the ICH (International Council for Harmonization). The discussion delves into the roles of regulatory affairs professionals, their impact on the drug development process, and how they ensure safety, consistency, and overall compliance. We also touch upon Title 21 of the Code of

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23:50

105 – Season 7 Recap & Future Directions (S7E15)

From Concept to Medicine - A Comprehensive Drug... ·

2025/04/27

This episode recaps the key formulation and drug delivery advancements covered throughout Season 7, connecting the major takeaways to future regulatory and post-marketing challenges. It discusses how lessons learned from past experiences are shaping the next wave of innovation in drug product design. The episode previews upcoming topics, including compliance, real-world effectiveness, and evolving industry trends, fostering a forward-looking discussion that links past insights to future

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17:06

104 – Advanced Drug Delivery Systems (S7E14)

From Concept to Medicine - A Comprehensive Drug... ·

2025/04/27

This episode explores next-generation drug delivery technologies, including nanocarriers, liposomes, and implantable devices. It delves into the science behind these innovations, highlighting their advantages over conventional methods and showcasing their real-world clinical applications. The discussion emphasizes how these advanced systems improve drug efficacy, reduce side effects, and enable targeted therapies, providing practical examples.Beyond simply administering medication, advanced drug

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15:44

103 - Patient-Centric Design in Drug Delivery (S7E13)

From Concept to Medicine - A Comprehensive Drug... ·

2025/04/27

This episode examines how patient-focused formulation strategies can enhance treatment adherence and improve therapeutic outcomes. It explores innovations in user-friendly dosage forms, delivery devices, and personalized medicine, highlighting their real-world clinical applications. The discussion emphasizes the impact of factors like ease of use, dosing convenience, and patient preferences on treatment success, providing practical examples of how design choices improve patient experience and health

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12:28

101 - Packaging, Storage, and Cold Chain (S7E11)

From Concept to Medicine - A Comprehensive Drug... ·

2025/04/27

This episode explores the crucial role of packaging, storage, and cold chain logistics in maintaining drug stability and efficacy. It discusses the challenges in selecting appropriate materials, controlling temperature, and ensuring proper distribution while adhering to stringent regulatory requirements. Real-world case studies highlight the consequences of storage failures and showcase innovations and compliance strategies in pharmaceutical logistics. The episode emphasizes the interconnected

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17:21

102 - Regulatory Aspects of Formulation (S7E12)

From Concept to Medicine - A Comprehensive Drug... ·

2025/04/27

This episode navigates the intricate regulatory landscape of drug formulation, covering key documentation, validation protocols, and compliance strategies. It explores how regulations shape product design, manufacturing processes, and quality control measures, providing real-world examples of navigating approval processes. The episode highlights the challenges of meeting global regulatory expectations and underscores the importance of robust formulation standards for ensuring patient safety.Beyond

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14:44

100 – Case Study: Formulation to Market Success (S7E10)

From Concept to Medicine - A Comprehensive Drug... ·

2025/04/27

This episode explores how innovative formulation strategies have overcome key challenges to successfully bring drugs to market. It presents a narrative-driven case study, highlighting the problem-solving, strategic decisions, and critical breakthroughs involved in formulation optimization, regulatory navigation, and maximizing commercial impact. Real-world examples from OPR&D and other sources illustrate the complexities and triumphs of drug development.Beyond simply discovering a promising

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18:28

99 - Analytical Methods in Formulation Testing (S7E9)

From Concept to Medicine - A Comprehensive Drug... ·

2025/04/27

This episode delves into the crucial role of analytical methods in ensuring formulation integrity, potency, and performance. It discusses key techniques used for product release and stability assessment, highlighting industry standards and regulatory expectations. Real-world examples and case studies illustrate the challenges and solutions encountered in formulation analysis. The episode emphasizes the importance of precise and accurate analytical methods for safeguarding drug quality.Beyond simply

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12:22

98 - Quality by Design in Formulation (S7E8)

From Concept to Medicine - A Comprehensive Drug... ·

2025/04/27

This episode explores Quality by Design (QbD) in drug formulation, focusing on its systematic approach to process design, risk management, and defining critical quality attributes (CQAs). It discusses how QbD enhances consistency, efficiency, and regulatory compliance in drug manufacturing. Real-world case studies from OPR&D sources highlight practical applications of QbD in formulation development. The episode emphasizes the proactive nature of QbD and its focus on building quality into the

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17:23

97 - Stability Indicating Methods & Shelf-life (S7E7)

From Concept to Medicine - A Comprehensive Drug... ·

2025/04/27

This episode covers the essential methods used to assess drug stability and predict shelf life, ensuring long-term product quality. It explains the concept of stability-indicating methods and their crucial role in distinguishing between the active drug and its degradation products. The discussion delves into the importance of validated analytical methods for ensuring accuracy and reliability in stability testing. Real-world examples and case studies illustrate the application of these principles in

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16:50

96 - Controlled Release & Targeted Delivery (S7E6)

From Concept to Medicine - A Comprehensive Drug... ·

2025/04/27

This episode explains how controlled release and targeted delivery systems optimize therapeutic outcomes and minimize side effects. It explores the use of polymer-based systems as tiny time-release capsules for drugs, and discusses mechanism-driven designs that utilize specific triggers in the body to release medication where it's needed. Real-world examples from research papers, particularly OPR&D publications, illustrate the principles behind these technologies. The episode emphasizes the

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20:53

95 – Overview of Drug Delivery Technologies (S7E5)

From Concept to Medicine - A Comprehensive Drug... ·

2025/04/27

This episode surveys various drug delivery systems, from traditional oral forms to advanced injectables, transdermal patches, and other novel approaches. It explores the factors affecting oral bioavailability, highlighting the challenges a drug molecule faces as it journeys through the body. The discussion delves into the role of excipients in oral dosage forms, explaining how they contribute to drug release, stability, and patient acceptability. Real-world examples and case studies illustrate the

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17:23

94 - Formulation Challenges for Biologics &...

From Concept to Medicine - A Comprehensive Drug... ·

2025/04/27

This episode tackles the unique challenges encountered when formulating biologics and injectables, particularly regarding sterility and stability. It compares and contrasts the formulation challenges of small molecule drugs versus biologics, highlighting the complexities associated with larger, more fragile biomolecules. The discussion explores the stringent manufacturing processes required for injectables to ensure sterility and prevent contamination. Real-world examples from OPR&D and other

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17:18

93 – Oral Dosage Formulation Strategies (S7E3)

From Concept to Medicine - A Comprehensive Drug... ·

2025/04/27

This episode focuses on the intricacies of formulating oral medications, specifically tablets and capsules, for optimal bioavailability and stability. It examines the crucial factors influencing oral drug absorption, including dissolution rate and solubility, and discusses how formulation scientists address challenges related to poorly soluble drugs. The episode explores various techniques employed to enhance drug dissolution and absorption, such as particle size reduction, co-solvents, and

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15:28

92 - Excipients: Roles and Selection (S7E2)

From Concept to Medicine - A Comprehensive Drug... ·

2025/04/27

This episode delves into the critical role of excipients, the inactive ingredients in medications, in drug formulation. It explains how these often-overlooked components are carefully chosen to enhance stability, delivery, and patient acceptability. The episode explores the various functions of excipients, from stabilizing the API to aiding in its dissolution and absorption in the body. It discusses how excipients can be tailored to specific patient groups, such as children or individuals with

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11:19

91 - Fundamentals of Formulation Development (S7E1)

From Concept to Medicine - A Comprehensive Drug... ·

2025/04/27

This episode introduces the fundamental principles of transforming a raw active pharmaceutical ingredient (API) into a stable and effective drug product. It delves into the crucial goals of formulation development, such as ensuring stability, maximizing efficacy, prioritizing safety, and achieving patient acceptability. The episode explores common challenges faced by researchers, including issues with solubility, stability, and drug-drug interactions. Real-world examples from scientific literature,

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270 results

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