Mostrando títulos en Química

Reporter Sam Kean reveals the periodic table as it’s never been seen before. Not only is it one of man's crowning scientific achievements, it's also a treasure trove of stories of passion, adventure, betrayal, and obsession. The infectious tales and astounding details in The Disappearing Spoon follow carbon, neon, silicon, and gold as they play out their parts in human history, finance, mythology, war, the arts, poison, and the lives of the (frequently) mad scientists who discovered them.

Chemistry and Our Universe: How It All Works is your in-depth introduction to this vital field, taught through 60 engaging half-hour lectures that are suitable for any background or none at all. Covering a year’s worth of introductory general chemistry at the college level, plus intriguing topics that are rarely discussed in the classroom, this amazingly comprehensive course requires nothing more advanced than high-school math. Your guide is Professor Ron B. Davis, Jr., a research chemist and award-winning teacher at Georgetown University.

Best-selling author Mark Sloan is the creator of the popular blog Endalldisease, which delivers evidence-based health information and has helped tens of thousands of people get healthy. After losing his mother to cancer at age 12, Mark has committed his life to finding safer and more effective therapies for diseases of all kinds. Methylene Blue is your ultimate guide for understanding what disease is, what disease isn’t, and how to use methylene blue to dramatically enhance your health and quality of life.

Napoleon's Buttons is the fascinating account of 17 groups of molecules that have greatly influenced the course of history. These molecules provided the impetus for early exploration, and made possible the voyages of discovery that ensued. The molecules resulted in grand feats of engineering and spurred advances in medicine and law; they determined what we now eat, drink, and wear. A change as small as the position of an atom can lead to enormous alterations in the properties of a substance.

This episode presents a case study of a pharmaceutical company overcoming a post-approval regulatory hurdle. The discussion focuses on the strategies employed, including negotiation with regulatory agencies, problem-solving approaches, and the ultimate resolution of the challenge. The importance of being dynamic, and the historical context of drug regulation are highlighted.Real-world examples, such as Vioxx (market withdrawal due to cardiovascular risks) and Thalidomide (birth defects leading to stricter regulations), are used to illustrate key lessons learned. The episode highlights the ...

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 regulatory agencies responded. We'll examine the challenges of underreporting and signal ...

In this groundbreaking episode, we explore the revolutionary world of molecular 3D printing, where digital design meets chemical synthesis at the nanoscale. Through fascinating interviews with leading synthetic chemists and materials scientists, we'll uncover how precise spatial control of molecular building blocks is enabling the creation of complex structures with unprecedented accuracy. Our journey takes us through cutting-edge laboratories where automated synthesis platforms are combining artificial intelligence with robotic precision to construct molecules layer by layer. We'll examine ...

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 regulations.We'll delve into critical regulatory documents and their practical impact, illustrating how ...

In this illuminating episode, we dive into the fascinating world of enzymatic bioremediation, where nature's own cleanup crew takes center stage in environmental restoration. Through expert interviews with environmental microbiologists and biochemists, we'll explore how specialized enzymes can break down persistent pollutants into harmless compounds. We'll examine groundbreaking case studies where engineered microorganisms have successfully restored contaminated soil and water systems, demonstrating the power of biological solutions to environmental challenges. Our investigation reveals how ...

This episode examines how patient registries support long-term safety and outcome studies in the pharmaceutical industry. We discuss the design, data collection, and analytical methods used in these registries. The conversation highlights their role in tracking rare adverse events, assessing treatment effectiveness over time, and understanding disease progression.Real-world examples from chronic disease registries, post-market drug monitoring programs, and biologics safety studies are used to illustrate the key benefits and lessons learned. The episode emphasizes the importance of high-quality...

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 gather and analyze post-market data, including data mining and signal detection techniques. The ...

This episode explores how digital technologies and data analytics are transforming pharmacovigilance and post-market surveillance. We discuss the use of mobile apps, wearables, AI-driven analytics, and big data integration in detecting adverse events and improving patient safety.The conversation highlights real-world applications, such as the FDA's Sentinel Initiative, AI signal detection, and real-time patient monitoring tools. Case studies are used to illustrate the impact and challenges of these technologies. The episode emphasizes the potential of digital tools to enhance the efficiency ...

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 identified and managed. The discussion covers the difference between observations in clinical trials ...

This episode outlines the inspection and audit processes used by regulatory agencies, such as the FDA, to ensure compliance with regulations in drug manufacturing and clinical trials. The conversation covers preparation for inspections, the conduct of audits, and follow-up steps. Documented examples highlight key aspects of the process.We highlight real-world examples of enforcement actions, including Form 483 observations, warning letters, and consent decrees, to illustrate the consequences of non-compliance. The discussion emphasizes the importance of maintaining meticulous records, adhering...

This episode focuses on Risk Evaluation and Mitigation Strategies (REMS) and their crucial role in ensuring drug safety post-approval. We explore how REMS programs are developed, implemented, and monitored, highlighting key components such as ETASU (Elements to Assure Safe Use), communication plans, and monitoring requirements. The discussion emphasizes the collaborative effort between regulators and industry in designing and executing these programs.Real-world cases are used to illustrate the practical application of REMS. The episode examines the challenges of compliance and effectiveness in...

In this illuminating episode, we explore the fascinating world of self-healing concrete, a revolutionary material that's transforming infrastructure maintenance. Through detailed analysis, we'll investigate how microscopic capsules embedded within concrete matrix spring into action when cracks appear, releasing healing agents that solidify and repair damage automatically. Expert interviews with materials scientists reveal the sophisticated chemistry behind various self-healing mechanisms, from encapsulated polymers to bacterial spores that produce calcium carbonate. We'll examine how these ...

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 Federal Regulations, specifically part 312, regarding IND (Investigational New Drug) ...

In this fascinating episode, we explore the cutting-edge world of enzyme engineering, where scientists are revolutionizing biotechnology by redesigning nature's molecular machines. Through detailed analysis, we'll delve into how researchers are using techniques like directed evolution and rational design to create custom-made enzymes for specific industrial and medical applications. Expert interviews with biochemists reveal the intricate process of modifying enzyme structures to enhance their performance, stability, and specificity. We'll examine groundbreaking applications in pharmaceutical ...

This episode delves into the increasing importance of real-world evidence (RWE) in informing post-approval drug safety and effectiveness assessments. We discuss key data sources, including electronic health records (EHRs), insurance claims data, patient registries, and even social media. Analytical platforms, such as AI-driven signal detection and machine learning models, are explored.The conversation highlights how RWE influences regulatory decisions, label updates, and the development of risk mitigation strategies. Real-world case studies from post-market surveillance programs are used to ...

This episode explores how drug labels evolve after a medication has been approved, including safety updates, new indications, and the addition of black box warnings. We discuss the regulatory commitments that companies must meet, such as post-market studies and REMS (Risk Evaluation and Mitigation Strategies) requirements. Examples of communicating with healthcare professionals and examples are shared.The conversation highlights communication strategies for informing healthcare providers and patients about these label changes. Real-world examples, such as label changes for opioids, biologics, ...