Poor Quality Pharmaceuticals in Global Public Health, Kimura Satoru, Nakamura Yasuhide
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: The Handbook of Microbiological Quality Control provides a unique distillation of material by providing a wealth microbiological information not only on the practical issues facing the company microbiologist today, but also the underlying principles of microbiological quality assurance. The book provides guidance on safe microbiological practices, including laboratory design and sampling techniques, and considers the design storage, use and quality control of microbiological culture in depth. All the chapters have been written by leading experts in this field, making the Handbook the essential reference source for the professional microbiologist.
Название: Natural Pharmaceuticals and Green Microbial Technology ISBN: 1771888814 ISBN-13(EAN): 9781771888813 Издательство: Taylor&Francis Рейтинг: Цена: 20059.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This volume presents some of the latest research and applications in using natural substances and processes for pharmaceutical products. It presents an in-depth examination of the chemical and biological properties of selected natural products.
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.
Автор: Hansen Steen Honor Название: Bioanalysis of Pharmaceuticals ISBN: 1118716825 ISBN-13(EAN): 9781118716823 Издательство: Wiley Рейтинг: Цена: 7437.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Bioanalysis of Pharmaceuticals: Sample Preparation, Separation Techniques and Mass Spectrometry is the first student textbook on the separation science and mass spectrometry of pharmaceuticals present in biological fluids with an educational presentation of the principles, concepts and applications.
Автор: Duran-Alvarez, Juan Carlo Название: Pharmaceuticals In Marine And Coastal Environments,1 ISBN: 0081029713 ISBN-13(EAN): 9780081029718 Издательство: Elsevier Science Рейтинг: Цена: 26107.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Pharmaceuticals in Marine and Coastal Environments: Occurrence, Effects, and Challenges in a Changing World is divided into three sections that address a) coastal areas as the main entrance of pharmaceuticals into the ocean, b) the occurrence and distribution of pharmaceuticals in the environmental compartments of the ocean media, and c) the effects that such pollutants may cause to the exposed marine organisms. With its comprehensive discussions, the book provides a wide depiction of the current state-of-the-art on these topics in an effort to open new sources of investigation and find suitable solutions.
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: Kimura Название: Poor Quality Pharmaceuticals in Global Public Health ISBN: 9811520887 ISBN-13(EAN): 9789811520884 Издательство: Springer Рейтинг: 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.
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.
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