International Regulatory Harmonization Amid Globalization of Drug Development PDF Download
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Languages : en
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Book Description
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309284791
Category : Medical
Languages : en
Pages : 129
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Book Description
The past several decades have been a time of rapid globalization in the development, manufacture, marketing, and distribution of medical products and technologies. Increasingly, research on the safety and effectiveness of new drugs is being conducted in countries with little experience in regulation of medical product development. Demand has been increasing for globally harmonized, science-based standards for the development and evaluation of the safety, quality, and efficacy of medical products. Consistency of such standards could improve the efficiency and clarity of the drug development and evaluation process and, ultimately, promote and enhance product quality and the public health. To explore the need and prospects for greater international regulatory harmonization for drug development, the IOM Forum on Drug Discovery, Development, and Translation hosted a workshop on February 13-14, 2013. Discussions at the workshop helped identify principles, potential approaches, and strategies to advance the development or evolution of more harmonized regulatory standards. This document summarizes the workshop.
Author: Shin-yi Peng
Publisher: Edward Elgar Publishing
ISBN: 1788115562
Category : Electronic books
Languages : en
Pages : 407
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Book Description
Against the backdrop of the recent trend towards megaregional trade initiatives, this book addresses the most topical issues that lie at the intersection of law and technology. By assessing international law and the political economy, the contributing authors offer an enhanced understanding of the challenges of diverging regulatory approaches to innovation.
Author: Shahid Khan
Publisher: Bentham Science Publishers
ISBN: 9815036734
Category : Medical
Languages : en
Pages : 285
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Book Description
Advances in technology have enabled medicinal chemists to discover and formulate several highly specific, biocompatible, and non-toxic therapeutic agents for clinical applications. Nanotechnology has achieved significant progress in the last few decades and is crucial in every field of science and technology. Nanotechnology-based pharmaceuticals offer multifaceted and alternative methodologies in comparison to the limitations of many conventional clinical therapies. Expertise in designing and developing nanoformulations has helped in targeted drug delivery. Recently, the use of innovative therapeutic agents, particularly in nanomedicine, has accounted for a significant portion of the global pharmaceutical market and is predicted to continue to grow rapidly in the near future. Nanotherapeutic Strategies and New Pharmaceuticals is an accessible multi-part reference which informs the reader about several new techniques based on nanotechnology. The chapters explain relevant topics in detail. The book is designed to encourage and help undergraduate, graduate and post-graduate students in the field of nanotherapeutics, pharmaceuticals and bio-organic chemistry through the use of didactic language and simple illustrations. Part 2 of this book covers the potential of nanotherapeutics and natural therapies for treating neurological diseases, targeting ion channels, signal transduction therapy, gene therapy of single gene mutation diseases and for nanoformulations for special purposes such as wound healing and stimuli-responsive drug delivery. The book also features a chapter that summarizes the types of nanoparticles tailored for specific molecular targets that mediate different diseases. The book set serves as a textbook for students in pharmacology and medical biochemistry, as well as a quick reference for researchers on bio-organic chemistry, as well as general readers interested in nanomedicine.
Author: Joseph Francois
Publisher: Cambridge University Press
ISBN: 1108485537
Category : Business & Economics
Languages : en
Pages : 385
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Book Description
Provides a contemporary overview of key issues related to non-tariff trade policy measures and domestic regulation.
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309498635
Category : Medical
Languages : en
Pages : 169
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Book Description
Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today's world, what policy makers need to know about today's regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 030904491X
Category : Medical
Languages : en
Pages : 225
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Book Description
Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.
Author: Dani Rodrik
Publisher: OUP Oxford
ISBN: 0191634255
Category : Political Science
Languages : en
Pages : 442
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Book Description
For a century, economists have driven forward the cause of globalization in financial institutions, labour markets, and trade. Yet there have been consistent warning signs that a global economy and free trade might not always be advantageous. Where are the pressure points? What could be done about them? Dani Rodrik examines the back-story from its seventeenth-century origins through the milestones of the gold standard, the Bretton Woods Agreement, and the Washington Consensus, to the present day. Although economic globalization has enabled unprecedented levels of prosperity in advanced countries and has been a boon to hundreds of millions of poor workers in China and elsewhere in Asia, it is a concept that rests on shaky pillars, he contends. Its long-term sustainability is not a given. The heart of Rodrik’s argument is a fundamental 'trilemma': that we cannot simultaneously pursue democracy, national self-determination, and economic globalization. Give too much power to governments, and you have protectionism. Give markets too much freedom, and you have an unstable world economy with little social and political support from those it is supposed to help. Rodrik argues for smart globalization, not maximum globalization.
Author: Graham Dukes
Publisher: Edward Elgar Publishing
ISBN: 1783471107
Category : Business & Economics
Languages : en
Pages : 419
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Book Description
The pharmaceutical industry exists to serve the community, but over the years it has engaged massively in corporate crime, with the public footing the bill. This readable study by experts in medicine, law, criminology and public health documents the pr
Author: Mr. Nagineni Sudarshan Rao
Publisher: JEC PUBLICATION
ISBN: 9358506393
Category : Medical
Languages : en
Pages : 291
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Book Description
Welcome to the world of Advanced Biopharmaceutics & Pharmacokinetics, a field that lies at the intersection of pharmaceutical science, medicine, and technology. This book represents an exploration into the intricate mechanisms governing the fate of drugs in the human body, the evolving landscape of drug delivery systems, and the cutting-edge methodologies shaping the future of pharmacokinetics. In the ever-evolving landscape of pharmaceuticals, the quest for optimizing drug delivery, enhancing therapeutic efficacy, and minimizing adverse effects has become increasingly complex. This book seeks to unravel these complexities by delving into the advanced principles of biopharmaceutics and pharmacokinetics, providing a comprehensive guide for researchers, practitioners, and students in the pharmaceutical sciences. The journey into Advanced Biopharmaceutics & Pharmacokinetics begins with a thorough examination of the fundamental concepts that underpin drug absorption, distribution, metabolism, and excretion. From there, we navigate through the intricacies of drug formulation and delivery systems, exploring the latest innovations in nanomedicine, biosimilars, and targeted drug delivery. Throughout the chapters, we highlight the pivotal role of pharmacokinetics in drug development, emphasizing its importance in optimizing dosage regimens, understanding drug interactions, and individualizing therapies in the era of precision medicine. The integration of advanced technologies, such as systems pharmacology and therapeutic drug monitoring, further enriches the discussion, offering a glimpse into the future of pharmacokinetic research.
