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Fundamentals of Biologicals Regulation, Sheets, Rebecca


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Автор: Sheets, Rebecca
Название:  Fundamentals of Biologicals Regulation
Перевод названия: Ребекка Шитс: Основания биорегулирования
ISBN: 9780128092903
Издательство: Elsevier Science
Классификация:
ISBN-10: 0128092904
Обложка/Формат: Paperback
Страницы: 224
Вес: 0.94 кг.
Дата издания: 01.05.2017
Язык: English
Размер: 193 x 235 x 27
Читательская аудитория: Professional & vocational
Подзаголовок: Vaccines and biotechnology medicines
Ссылка на Издательство: Link
Рейтинг:
Поставляется из: Европейский союз
Описание:

Fundamentals of Biologicals Regulation: Vaccines and Biotechnology Medicines serves as an introduction to the international regulatory arena in which biologicals are developed and offers an overview of the processes and insight into the scientific concepts underpinning global regulations. This book will provide multiple levels of readership with guidance on basic concepts, a detailed look at regulatory challenges, and practical insight into how regulators consider regulatory science and regulatory process issues across various regions. With numerous case studies, learning activities, and real-world examples across several classes of biotechnological products, this book is a valuable and comprehensive resource for graduate students, professors, regulatory officials, and industry scientists working with biologicals.



Drug and Biological Development

Автор: Evens
Название: Drug and Biological Development
ISBN: 0387329781 ISBN-13(EAN): 9780387329789
Издательство: Springer
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Цена: 85670.00 T
Наличие на складе: Поставка под заказ.
Описание: The book is a complete discussion of product development in the pharmaceutical and biotechnology industries from discovery, to product launch, and through life cycle management. Format is optimized for education and training of health care professionals, especially fellows in training (MD, PharmD, PhD), at universities. Format of the book is a set of figures, tables and lists, that can become power-point style slides as well, and the detailed narrative descriptions, including real-life examples, illustrations, controversies in industry, and references. Industry and research experts (multidisciplinary – MD, PharmD, and PhD) are editors and authors. An added CD-ROM (slides only) enhances utility and marketability of book to course directors, providing the highly sought after slides for lectures.

Pharmacokinetic Optimization in Drug Research: Biological, Physicochemical, and Computational Strategies

Автор: Bernard Testa
Название: Pharmacokinetic Optimization in Drug Research: Biological, Physicochemical, and Computational Strategies
ISBN: 3906390225 ISBN-13(EAN): 9783906390222
Издательство: Wiley
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Цена: 153120.00 T
Наличие на складе: Невозможна поставка.
Описание: In this age of combinatorial chemistry and high-throughput technologies, bioactive compounds called hits are discovered by the thousands. However, the road that leads from hits to lead compounds and then to pharmacokinetically optimized clinical and drug candidates is very long indeed. As a result, the screening, design, and optimization of pharmacokinetic properties has become the bottleneck and a major challenge in drug research. To shorten the time-consuming develop-ment and high rate of attrition of active compounds ultimately doomed by hidden pharmacokinetic defects, drug researchers are coming to incorporate structure-permeation, structure-distribution, structure-metabolism, and structure-toxicity relations into drug-design strategies. To this end, powerful biological, physicochemical, and computational approaches are being developed whose objectives are to increase the clinical relevance of drug design, and to eliminate as soon as possible compounds with unfavorable physicochemical properties and pharmacokinetic profiles. Toxicological issues are also of utmost importance in this paradigm. There was, hence, an urgent need for a book covering this field in an authoritative, didactic, comprehensive, factual, and conceptual manner. In this work of unique breadth and depth, international authorities and practicing experts from academia and industry present the most modern biological, physicochemical, and computational strategies to optimize gastrointestinal absorption, protein binding and distribution, brain permeation, and metabolic profile. The biological strategies emphasized in the book include cell cultures and high-throughput screens. The physicochemical strategies focus on the determination and interpretation of solubility, lipophilicity, and related molecular properties as factors and predictors of pharmacokinetic bahavior. Particular attention is paid to the lipophilicity profiles of ionized compounds, to lipophicity measurements in anisotropic media (liposomes/water, IAM columns), and to permeability across artificial membranes. Computational strategies comprise virtual screening, molecular modelling, lipophilicity, and H-bonding fields and their importance for structure-disposition relations. This book is both about theoretical and technological breakthroughs. Thus, molecular properties are contemplated from a dual perspective, namely a) their interpretation in biological and/or physicochemical terms, and b) their value in screening, lead optimization, and drug-candidate selection. In addition to its 33 chapters, the book includes a CD-ROM containing the invited lectures, oral communications and posters (in full version) presented at the Second LogP Symposium, 'Lipophilicity in Drug Disposition -- Practical and Computational Approaches to Molecular Properties Related to Drug Permeation, Disposition and Metabolism', held at the University of Lausanne in March 2000.

Drug Testing in Alternate Biological Specimens

Автор: Y.H. Caplan; Amanda J. Jenkins
Название: Drug Testing in Alternate Biological Specimens
ISBN: 1617377325 ISBN-13(EAN): 9781617377327
Издательство: Springer
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Цена: 186340.00 T
Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Although the specimen of choice in the US drug testing industry is urine, and serum in clinical medicine, interest has recently grown in the use of other matrices as drug testing media. This book provides researchers and forensic toxicologists with a convenient general text summarizing the state of knowledge today.

Pharmacokinetic Profiling in Drug Research: Biological, Physicochemical, and Computational Strategies

Автор: Bernard Testa
Название: Pharmacokinetic Profiling in Drug Research: Biological, Physicochemical, and Computational Strategies
ISBN: 3906390357 ISBN-13(EAN): 9783906390352
Издательство: Wiley
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Цена: 239660.00 T
Наличие на складе: Поставка под заказ.
Описание: Informatics and robotics are the workhorses of a technological revolution in drug research. On them are based combinatorial chemistry, which yields compounds by the many thousands, and high-throughput bioassays, which screen them for activity. The results are avalanches of `hits`, which invade the databases like swarms of locusts.


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