Life Sciences Research to Product Development: Regulatory Requirement Transforming, Volume 1, Chattopadhyay, Pronobesh ; Goyary, Danswrang
Название: Generic drug product development ISBN: 036738437X ISBN-13(EAN): 9780367384371 Издательство: Taylor&Francis Рейтинг: Цена: 65320.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: Due to a worldwide need for lower cost drug therapy, use of generic and multi-source drug products have been increasing. To meet international patent and trade agreements, the development and sale of these products must conform to national and international laws, and generic products must prove that they are of the same quality and are therapeutically equivalent to the brand name alternative. However, many countries have limited resources to inspect and verify the quality of all drug products for sale in their country. This title discusses the worldwide legislative and regulatory requirements for the registration of generic and multi-source drug products.
Автор: Matthews, Brian R. Название: Pharmaceutical Product Licensing ISBN: 0136628834 ISBN-13(EAN): 9780136628835 Издательство: Taylor&Francis Рейтинг: Цена: 112290.00 T Наличие на складе: Нет в наличии.
Автор: Sidebottom, Charles Название: International Labeling Requirements for Medical Devices, Medical Equipment and Diagnostic Products ISBN: 0367395169 ISBN-13(EAN): 9780367395162 Издательство: Taylor&Francis Рейтинг: Цена: 65320.00 T Наличие на складе: Нет в наличии. Описание: Completely revised, this second edition provides the practical, hands-on labeling information needed to secure rapid regulatory approval, gain marketplace acceptance, and assure user comprehension. A complete guide to all aspects of advertising, labeling, and packaging, it explains the relevant laws, regulations, and requirements in major markets worldwide and provides examples of compliance and noncompliance. Coverage includes requirements such as text, dimensions, type sizes, graphic elements, symbols, and language for implantable devices, sterile devices, over the counter products, in vitro diagnostic products, radiation emitting devices, contraceptive devices, and more.
Автор: Poliskie Название: Solar Module Packaging ISBN: 1138077658 ISBN-13(EAN): 9781138077652 Издательство: Taylor&Francis Рейтинг: Цена: 83690.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание:
While global demand for photovoltaic (PV) modules has increased approximately 45 percent per year over the past decade, PV modules must be durable and inexpensive to compete with traditional energy resources. Often overlooked as a means to improve solar technology, polymer packaging is not only the key to protecting fragile solar cells from environmental factors, but is also the critical path for increasing the power performance of a PV module
Solar Module Packaging: Polymeric Requirements and Selection explores current and future opportunities in PV polymeric packaging, emphasizing how it can simultaneously reduce cost, increase weatherability, and improve a PV module's power. The book offers an insider's perspective on the manufacturing processes and needs of the solar industry and reveals opportunities for future material development and processing.
A broad survey of the polymeric packaging of solar cells, the text covers various classifications of polymers, their material properties, and optimal processing conditions. Taking a practical approach to material selection, it emphasizes industrial requirements for material development, such as cost reduction, increased material durability, improved module performance, and ease of processing. Addressing cost and profitability, the author examines the economics behind polymeric packaging and how it influences the selection process used by solar companies.
Suitable for nonspecialists in polymer science, the book provides a basic understanding of polymeric concepts, fundamental properties, and processing techniques commonly used in solar module packaging. It presents guidelines for using polymers in commercial PV modules as well as the tests required to establish confidence in the selection process.
Автор: Carlos Tello Lacal Название: Photosynthesis and Plant Light Requirements ISBN: 177361049X ISBN-13(EAN): 9781773610498 Издательство: Mare Nostrum (Eurospan) Рейтинг: Цена: 204210.00 T Наличие на складе: Невозможна поставка. Описание: Photosynthesis plays a central role in sustaining life. Understanding the functioning of photosynthesis is the first step towards increasing its performance. This book reviews the state-of-the-art knowledge on different aspects of photosynthesis, including the potential application of recent findings.
Название: Challenges and Opportunities for Crop Production in Dry and Saline Environments in ARASIA Member States: Specific Safety Requirements ISBN: 9201019181 ISBN-13(EAN): 9789201019189 Издательство: Mare Nostrum (Eurospan) Рейтинг: Цена: 16630.00 T Наличие на складе: Невозможна поставка. Описание: Serves as a referencing guide for Member States and interested specialized readers wishing to work on agriculture in dry and saline environments, in particular in the Middle East region. All information and instructions are based on successful and sound practices applied in pertaining Member States for sustainable cropping of salt affected soils.
Автор: P.L. Chambers; C.M. Chambers Название: New Toxicology for Old ISBN: 3540114068 ISBN-13(EAN): 9783540114062 Издательство: Springer Рейтинг: Цена: 121110.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: Nervous system is in the most cases a likely target for the untoward effects of chemicals.
Although the Bioequivalence (BE) requirements in many global jurisdictions have much in common, differences in certain approaches and requirements such as definitions and terms, choice of comparator (reference) product, acceptance criteria, fasted and fed studies, single and multi-dose studies, biowaivers and products not intended for absorption into the systemic circulation (locally acting medicines and dosage forms), amongst others, provide food for thought that standardisation should be a high priority objective in order to result in a harmonized international process for the market approval of products using BE. An important objective of Bioequivalence Requirements in Various Global Jurisdictions is to attempt to gather the various BE requirements used in different global jurisdictions to provide a single source of relevant information. This information from, Brazil, Canada, China, European Union, India, Japan, MENA, Russia South Africa, the
USA and WHO will be of value to drug manufacturers, regulatory agencies, pharmaceutical scientists and related health organizations and governments around the world in the quest to harmonize regulatory requirements for the market approval of generic products.
Автор: Peter Ulmschneider Название: Intelligent Life in the Universe ISBN: 364206938X ISBN-13(EAN): 9783642069383 Издательство: Springer Рейтинг: Цена: 130590.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: This book examines the origins, development and fate of intelligent species in the observable part of our universe. There is emphasis on the geological conditions and consequences of life`s conquest of land as the pre-condition for the emergence of life with our type of technical intelligence.
Автор: Goyal Megh R., Aladakatti Basamma K., Kumar Pradeep Название: Engineering Interventions in Sustainable Trickle Irrigation: Irrigation Requirements and Uniformity, Fertigation, and Crop Performance ISBN: 1774636395 ISBN-13(EAN): 9781774636398 Издательство: Taylor&Francis Рейтинг: Цена: 84710.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: This new volume, Engineering Interventions in Sustainable Trickle Irrigation: Irrigation Requirements and Uniformity, Fertigation, and Crop Performance, presents valuable research that evaluates crop water and fertigation requirements, examines optimum irrigation and fertigation scheduling, and analyzes the performance of agricultural cro
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