Showing titles in Chemistry

Explore the European Medicines Agency (EMA) and the ways this group works with international bodies to regulate clinical trials. This podcast episode discusses the ICH harmonization, and how this integrates with global standards, while taking into account the regional differences.Explore ICH's E6R3 draft guideline and ICH's Q series which provides guidance on how to achieve consistent quality in pharmaceutical manufacturing globally. It also covers what regulators in the European Union use. This podcast explores how they navigate differing regulations and how it affects the creation of ...

This episode discusses the move toward sustainable practices and green chemistry in drug development and manufacturing. Dialogue on environmental initiatives, innovative chemistry approaches, and documented case studies is provided. There is much discussion on pollution, waste, resource depletion, and economics.The episode also explores the 12 core principles and some of the most important, including waste prevention and atom economy. The conversation goes into detail about examples, like safer solvents and how to use them. There is much discussion about specific documents, such as the 20201 D...

In this episode, we revisit the critical operational components that make up clinical research. This discussion will offer effective methods for monitoring the study process and the key quality assurance procedures that are necessary to support compliance.We have prepared some practical advice that will give insight into optimizing your processes and will include how to successfully manage risk and prepare for audits. The overall goal is to make these clinical processes as efficient as possible while keeping everything complaint with current good clinical practices.This information will be ...

This episode traces the progression of cGCP standards, commencing from the foundational ethical principles of early clinical research through to the contemporary regulatory landscape. Key milestones are examined, accompanied by landmark cases and regulatory transitions that have significantly shaped current practices in the field. Understanding how these elements came to be what they are today will make the reasoning behind them more obvious.The episode further examines how these historical precedents inform present-day clinical trial conduct, emphasizing the importance of learning from past ...

This episode explored models of global collaboration and open innovation that are transforming drug development worldwide. Dialogue on partnerships, data sharing, and collaborative research with real-world case references is provided. Discussions on global collaboration and why it is a growing necessity are included. There are also many OPR&D examples to show the many forms of collaboration.Specific examples of global collaboration are highlighted. The discussion on the International Council for Harmonization and its impact on drug regulation, especially for international research, is included...

Please join us today for our Expert Mentor series by The Aesthetic Doctor Podcast. Dr. Borger is joined by Dr. Julia Milman, the founder and owner of Dr. Julia Milman’s Aesthetic Medicine, a boutique practice located in the northern suburbs of Chicago, Illinois. With over a decade of experience and a team of six, Dr. Milman has taken a refreshingly unique approach to building her practice—no advertising, no promotions, and no memberships. We’ll dive into what that looks like and why it works, and how she has made her practice so successful. Dr. Julia Milman Links: Website: ...

This episode discusses strategic risk management and flexible design to prepare for future uncertainties in drug development. Dialogue on contingency planning, scenario analysis, and adaptive strategies with real-world examples is presented. Analysis is focused on building adaptability into the process and thinking ahead.Various techniques for managing strategic risk, including contingency planning and flexible design, are analyzed. The role of regulatory requirements and the role of pharmaceutical processes are highlighted. Analysis of examples from Organic Process Research and Development (...

This episode is devoted to regulatory science. Discussions analyze how evolving regulatory science is adapting to innovative therapies and new technologies. Discussions on adaptive guidelines, flexible pathways, and global harmonization efforts using detailed case studies are also provided.In the world of regulatory science, challenges in AI, medical devices, and continuous manufacturing are analyzed. The regulatory side's evolution, the importance of global collaboration, and discussions from OPR&D and other organizations are highlighted.

This episode dives deep into how Al continues to influence every stage of drug research, from discovery to clinical trials. Discussion on new algorithms, data integration, and future potentials are backed by literature examples. The conversation includes what drives the need for Al, such as cost or speed, and the safety surrounding the use of Al.The integration of Al into many areas of drug development is highlighted, for example, with Inoplexus, Adamwise, and Biomotive. The integration of Al into structure and activity relations and NMR is also discussed. Additionally, The limitations of Al, ...

This episode looks ahead at emerging manufacturing innovations—such as modular and continuous systems—that promise efficiency gains. Conversation on technology trends, projected industry impacts, and documented case studies are analyzed. Discussion around the traditional methods are compared to these new technologies, such as 3-D printing and modular systems.The various processes and technologies, like modeling, simulation, and automation, that support the development of pharmaceutical products are highlighted. Examples from Organic Process Research and Development (OPR&D) are given to ...

📌زکریای رازی (Abu Bakr al-Razi) در این قسمت، روایت زندگی و اندیشه‌های زکریای رازی، پزشک و شیمیدان بزرگ ایرانی را می‌شنوید. راه ارتباطی : mailbox.catalyst@gmail.com

This episode examined the role of big data and digital health records in shaping future drug development decisions. A conversation on data analytics, privacy concerns, and clinical applications with detailed real-world insights is offered. There's talk about how Al and machine learning tools can find patterns and connections within the massive amounts of data.The conversation covers not only target finding and clinical trials but also real-world impacts of drug use, discussing PKPD and the microbiome. There's also important discussions on ethical and security considerations as related to ...

This episode explores how personalized development strategies (biomarker-driven trials, patient-centric design) are changing the field. Dialogue on integrating patient data and customizing treatment strategies with concrete examples is provided. This includes personalized medicine and its integration with today's society.A significant amount of time in the conversation is spent discussing biomarkers and their importance in creating specific drugs. Patient-centric design, the analysis of data with the use of AI, and pharmacokinetics/pharmodynamics all take up significant time in the ...

This episode recaps the entire series, summarizing key lessons and insights while looking forward to ongoing innovation. Final reflections by Host and SME, celebrating the learning journey and setting visions for the future are shared. Analysis of the major moments and topics of the year are featured, bringing the season full circle.The discussion highlights pre-clinical testing, the ADME, and GLP, then moves to covering each of the stages of a clinical trial, and regulatory requirements and ethics. Many of the new innovative tools, techniques, and methods of drug design and manufacturing are ...

This episode discusses the challenge of balancing rapid innovation with rigorous safety standards in modern drug development. Conversation on risk management, ethical considerations, and regulatory requirements are presented with detailed examples. Discussions start with how a drug process happens and why pre-clinical phases of research exist. The importance of the FDA and ICH guidelines is highlighted.Conversations on the need for innovation versus the ethical need to make drugs and medical technologies safe. There is a discussion on models like sarcoma and the importance of pre-clinical ...

This episode analyzed how anticipated policy changes and regulatory reforms may impact the drug development landscape. Discussion on current debates, potential shifts, and strategic responses backed by recent examples were presented. Discussions on current policy standards are included and discussions about proposed regulatory shifts are also provided.Among the areas covered are dietary supplements with new dietary ingredients. Rules for conducting clinical trials, and the Orphan Drug designation. Various pieces of literature from OPR&D were integrated into the discussion, as well as more ...

This episode explores novel clinical trial designs (basket, umbrella trials) aimed at increasing efficiency and patient benefit. Dialogue on design principles, adaptive features, and case studies from current literature are provided. Discussions around adaptive designs and the benefits as they relate to the future of drug development are analyzed.The efficiency gains of umbrella trials as compared to traditional development of cancer-treating pharmaceuticals are highlighted in detail. OPR&D and chemistry methods of creating new drugs and how these contribute to innovation in umbrella trials ...

This episode offers an overview of cutting-edge biotechnologies and gene therapies revolutionizing treatment options. It provides a narrative on breakthrough therapies, mechanisms, and regulatory challenges with real-world data. It further explores the origin of ideas that lead to amazing therapies, target selection, preclinical evaluation, and toxicology studies in animals.The conversation analyzes the FDA and the steps involved in pharmaceutical development. Discussing clinical trials, it explores all of the phases, the need for accurate data, and what happens when phase three trials fail. ...

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