Pharmaceutical product development is a multidisciplinary activity involving extensive efforts in systematic product development and optimization in compliance with regulatory authorities to ensure the quality, efficacy and safety of resulting products.
Pharmaceutical Product Development equips the pharmaceutical formulation scientist with extensive and up-to-date knowledge of drug product development and covers all steps from the beginning of product conception to the final packaged form that enters the market and lifecycle management thereof.
Applications of core scientific principles for product development are also thoroughly discussed in conjunction with the latest approaches involving design of experiment and quality by design with comprehensive illustrations based on practical case studies of several dosage forms.
The book presents pharmaceutical product development information in an easy-to-read mode with simplified theories, case studies and guidelines for students, academicians and professionals in the pharmaceutical industry. It is an invaluable resource and hands-on guide covering managerial, regulatory and practical aspects of pharmaceutical product lifecycle management.
Автор: C. Lumley; S.R. Walker Название: Improving the Regulatory Review Process ISBN: 9401072973 ISBN-13(EAN): 9789401072977 Издательство: Springer Рейтинг: Цена: 32004.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Regulatory review is the last major development hurdle that must be passed by a new medicine before it reaches the market. At a time when pharmaceutical companies are reviewing their R&D strategies, and attempting to reduce drug development times, it is extremely important that the review process is made as efficient as possible.
Описание: At a time when it is becoming usual for medicines to be developed for a global market and pharmaceutical companies are endeavouring to expedite the drug development process, Regulatory Authorities are concentrating on improving their efficiency and effectiveness.
Описание: While emphasizing conservation and sustainable strategies, this book provides steps to improve the manufacturing technologies used in creating products.
Автор: Geigert, John Название: Challenge of cmc regulatory compliance for biopharmaceuticals ISBN: 1461469155 ISBN-13(EAN): 9781461469155 Издательство: Springer Рейтинг: Цена: 30745.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book highlights the challenges facing quality assurance/quality control (QA/QC) in today`s biopharmaceutical environment and presents the strategic importance and value generated by QA/QC for their involvement in control of manufacturing.
Автор: Geigert, John Название: Challenge of cmc regulatory compliance for biopharmaceuticals ISBN: 1493943995 ISBN-13(EAN): 9781493943999 Издательство: Springer Рейтинг: Цена: 22359.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: In its new edition, this book reviews the challenges facing quality assurance and control (QA/QC) in today`s biopharmaceutical environment, putting into perspective the need for a graded approach to QA/QC from early clinical trials through market approval.
Описание: Part I, "Drug Assessment and Regulation," is based on the nine sessions of the course that ranged in focus from recent developments in the science of clinical pharmacology and drug development to discussions of whether and how the regulation of drug development can (or should) be harmonized internationally.
Автор: Daniele Pisanello Название: Chemistry of Foods: EU Legal and Regulatory Approaches ISBN: 3319034332 ISBN-13(EAN): 9783319034331 Издательство: Springer Рейтинг: Цена: 7685.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book concerns the EU legal and regulatory framework relating to Chemicals in Food. It is divided in two parts: the first section offers an introduction to the European General Food Law with an analysis of EFSA (the European Food Safety Authority) and a description of main features of food safety-related regulations. The second part focusses on the legislation finding application concerning chemicals in food from different viewpoints, namely: - the REACH regulation; - the enzyme, flavorings and additive regulatory framework; - the matter of contamination and veterinary drugs; - the use of Food contact materials. The final chapter addresses several considerations relating to chemical hazards and crisis management, highlighting shortcomings and lessons from experience.
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