Intellectual Property Law and Access to Medicines: TRIPS Agreement, Health, and Pharmaceuticals, Ragavan Srividhya, Vanni Amaka
Автор: Ward Kevin R., Matejtschuk Paul Название: Lyophilization of Pharmaceuticals and Biologicals: New Technologies and Approaches ISBN: 1493989278 ISBN-13(EAN): 9781493989270 Издательство: Springer Рейтинг: Цена: 16630.00 р. 23757.00-30% Наличие на складе: Есть (1 шт.) Описание: This detailed volume brings together leading practitioners in the freeze-drying community to address recent progress, not only in new analytical tools and applications of the data derived in cycle design but also in the manufacturing of lyophilized products in the healthcare sector - whether these be therapeutics, vaccines or diagnostic products - and indeed the equipment to deliver this scale of freeze-drying. Areas of focus include analytical and formulation issues, process monitoring and control, as well as post-lyophilization analysis. Written for the Methods in Pharmacology and Toxicology series, chapters include the type of expert advice that leads to superior results in the lab.
Authoritative and practical, Lyophilization of Pharmaceuticals and Biologicals: New Technologies and Approaches serves as an ideal guide for researchers working in or just seeking an update on this rapidly changing field.
Описание: Some two decades will shortly have passed since the WTO`s Trade Related Aspects of Intellectual Property Rights agreement came into force in 1995. This volume is the first cross-country analysis of how TRIPS has affected the capacity of 11 major low or medium income countries to produce generic drugs.
Автор: Abdul W. Basit; Simon Gaisford Название: 3D Printing of Pharmaceuticals ISBN: 3030080919 ISBN-13(EAN): 9783030080914 Издательство: Springer Рейтинг: Цена: 15372.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: 3D printing is forecast to revolutionise the pharmaceutical sector, changing the face of medicine development, manufacture and use. Potential applications range from pre-clinical drug development and dosage form design through to the fabrication of functionalised implants and regenerative medicine. Within clinical pharmacy practice, printing technologies may finally lead to the concept of personalised medicines becoming a reality. This volume aims to be the definitive resource for anyone thinking of developing or using 3D printing technologies in the pharmaceutical sector, with a strong focus on the translation of printing technologies to a clinical setting. This text brings together leading experts to provide extensive information on an array of 3D printing techniques, reviewing the current printing technologies in the pharmaceutical manufacturing supply chain, in particular, highlighting the state-of-the-art applications in medicine and discussing modern drug product manufacture from a regulatory perspective. This book is a highly valuable resource for a range of demographics, including academic researchers and the pharmaceutical industry, providing a comprehensive inventory detailing the current and future applications of 3D printing in pharmaceuticals. Abdul W. Basit is Professor of Pharmaceutics at the UCL School of Pharmacy, University College London. Abdul’s research sits at the interface between pharmaceutical science and gastroenterology, forging links between basic science and clinical outcomes. He leads a large and multidisciplinary research group, and the goal of his work is to further the understanding of gastrointestinal physiology by fundamental research. So far, this knowledge has been translated into the design of new technologies and improved disease treatments, many of which are currently in late-stage clinical trials. He has published over 350 papers, book chapters and abstracts and delivered more than 250 invited research presentations. Abdul is also a serial entrepreneur and has filed 25 patents and founded 3 pharmaceutical companies (Kuecept, Intract Pharma, FabRx). Abdul is a frequent speaker at international conferences, serves as a consultant to many pharmaceutical companies and is on the advisory boards of scientific journals, healthcare organisations and charitable bodies. He is the European Editor of the International Journal of Pharmaceutics.Abdul was the recipient of the Young Investigator Award in Pharmaceutics and Pharmaceutical Technology from the American Association of Pharmaceutical Scientists (AAPS) and is the only non-North American scientist to receive this award. He was also the recipient of the Academy of Pharmaceutical Sciences (APS) award.Simon Gaisford holds a Chair in Pharmaceutics and is Head of the Department of Pharmaceutics at the UCL School of Pharmacy, University College London. He has published 110 papers, 8 book chapters and 4 authored books. His research is focused on novel technologies for manufacturing medicines, particularly using ink-jet printing and 3D printing, and he is an expert in the physico-chemical characterisation of compounds and formulations with thermal methods and calorimetry.
Описание: Formally Plunkett's Biotech & Genetics Industry Almanac, this book is a complete reference guide to the business side of biotechnology, genetics, proteomics and related services. This new book contains complete profiles of the leading biotech companies; in-depth chapters on trends in genetics, technologies, statistics and finances; a handy glossary; and thorough indexes. For the first time, in one carefully-researched volume, you'll get all of the data you need. Topics include: biotechnology funding and investments; activities in Singapore, China and India; FDA; gene therapies; personalized medicine; systems biology; clinical trials; stem cells; therapeutic cloning; nanotechnology; agricultural biotechnology (GM seeds); drug delivery systems; and ethical issues. The book includes complete profiles on 350 top Biotech & Genetics companies, our own unique list of companies that are the leaders in biotechnology. All of the corporate profile information is indexed and cross-indexed. Includes contact names, addresses, Internet addresses, fax numbers and toll-free numbers, plus growth and hiring plans, finances, research, marketing, technology, acquisitions and much more for each firm. You'll find a complete overview, industry analysis and market research report in one superb, value-priced package.
Автор: Susan A. Griffiths; C. Lumley Название: Safety Evaluation of Biotechnologically-derived Pharmaceuticals ISBN: 9401060436 ISBN-13(EAN): 9789401060431 Издательство: Springer Рейтинг: Цена: 13974.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Considerable investment has been made by both pharmaceutical and biotechnology companies in pharmaceutical products of biotechnology. However, because relatively few of these products have been marketed, lack of relevant experience means that uncertainty still surrounds the most appropriate strategy for their safety evaluation. The 13th CMR International Workshop, held in February 1997, provided the opportunity for regulatory authority and industry experts from Europe, Japan and the USA to share their experiences of designing safety evaluation programmes for specific product classes: colony stimulating factors, growth factors, hormones, interferons, interleukins, monoclonal antibodies for therapeutic use, and gene therapy products. Participants worked together to recommend those studies that should be considered for such safety evaluation, and those that may be unnecessary. These recommendations subsequently made a valuable contribution to the ICH guideline Safety Studies for Biotechnological Products', which was finalised at ICH 4 in Brussels in July 1997. The Workshop proceedings not only describe the recommendations but also provide the reader with an appreciation of the science behind safety evaluation strategies used by experts, the influence of different regulatory systems on these strategies, and the type of data required by both toxicologists and clinicians before they have sufficient confidence to administer pharmaceutical products of biotechnology to humans.
Автор: Nupur Chowdhury Название: European Regulation of Medical Devices and Pharmaceuticals ISBN: 3319353217 ISBN-13(EAN): 9783319353210 Издательство: Springer Рейтинг: Цена: 13974.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: One of the primary functions of law is to ensure that the legal structure governing all social relations is predictable, coherent, consistent and applicable. Taken together, these characteristics of law are referred to as legal certainty. In traditional approaches to legal certainty, law is regarded as a hierarchical system of rules characterized by stability, clarity, uniformity, calculable enforcement, publicity and predictability. However, the current reality is that national legal systems no longer operate in isolation, but within a multilevel legal order, wherein norms created at both the international and regional level are directly applicable to national legal systems. Also, norm creation is no longer the exclusive prerogative of public officials of the state: private actors have an increasing influence on norm creation as well. Social scientists have referred to this phenomenon of interacting and overlapping competences as multilevel governance. Only recently have legal scholars focused attention on the increasing interconnectedness (and therefore the concomitant loss of primacy of national legal orders) between the global, European and national regulatory spheres through the concept of multilevel regulation. In this project the author uses multilevel regulation as a term to characterize a regulatory space in which the process of rule making, rule enforcement and rule adjudication (the regulatory lifecycle) is dispersed across more than one administrative or territorial level and amongst several different actors, both public and private. The author draws on the concept of a regulatory space, using it as a framing device to differentiate between specific aspects of policy fields. The relationship between actors in such a space is non-hierarchical and they may be independent of each other. The lack of central ordering of the regulatory lifecycle within this regulatory space is the most important feature of such a space. The implications of multilevel regulation for the notion of legal certainty have attracted limited attention from scholars and the demand for legal certainty in regulatory practice is still a puzzle. The book explores the idea of legal certainty in terms of the perceptions and expectations of regulatees in the context of medical products – specifically, pharmaceuticals and medical devices, which can be differentiated as two regulatory spaces and therefore form two case studies. As an exploratory project, the book necessarily explores new territory in terms of investigating legal certainty first in terms of regulatee perceptions and expectations and second, because it studies it in the context of multilevel regulation.
Описание: In recent years medicalization, the process of making something medical, has gained considerable ground and a position in everyday discourse. In this multidisciplinary collection of original essays, the authors expertly consider how issues around medicalization have developed, ways in which it is changing, and the potential shapes it will take in the future. They develop a unique argument that medicalization, biomedicalization, pharmaceuticalization and geneticization are related and co-evolving processes, present throughout the globe. This is an ideal addition to anthropology, sociology and STS courses about medicine and health.
Описание: In this examination of the early globalization of the pharmaceutical industry, Laurence Monnais argues that colonialism played a crucial part in the worldwide diffusion of modern medicines, speaking to contemporary concerns regarding over-reliance on pharmaceuticals, self-medication, and the accessibility of effective drug treatments.
Автор: Kimura Satoru, Nakamura Yasuhide Название: Poor Quality Pharmaceuticals in Global Public Health ISBN: 9811520917 ISBN-13(EAN): 9789811520914 Издательство: Springer Цена: 16769.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book aims to clarify the global aspects of poor quality pharmaceuticals, generic products in particular, becoming complicated through the process of IMPACT (International Medical Products Anti-Counterfeiting Taskforce) organized by the initiative of the World Health Organization (WHO) in 2006.
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