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: McCormick, Kate Jr, D. Wylie McVay Название: Pharmaceutical Process Design and Management ISBN: 1138255505 ISBN-13(EAN): 9781138255500 Издательство: Taylor&Francis Рейтинг: Цена: 7961.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: A quality product or service is the successful and profitable outcome of organising resources, as judged by the final customer. Every business unit needs processes in order to do this effectively; and all processes must be documented so that achievements can be measured and future improvements planned and implemented. Pharmaceutical Process Design and Management takes a step-wise approach to process management. It presents the various elements comprising a process (man, machine, materials, method and environment); it looks at quality control and quality assurance, tools for quality improvements and ways of structuring a process into discrete, fully accountable elements; it proposes that for processes to run successfully, all operators must be the initial problem-solvers; finally, it illustrates how, with the right tools, every problem can be broken down into solvable elements. Learn how to deploy a science and risk-based approach to pharmaceutical manufacturing, by taking a fundamental approach to process design and management and, as a consequence, keep your customers satisfied and your profits healthy.
Описание: This Brief concerns the chemical risk in food products from the viewpoint of microbiology. The chemical risks described in this book are related to food additives, contaminants by food packaging materials, chemicals from cleaning systems and microbial toxins.
Название: Pharmaceutical Chemistry ISBN: 0199655308 ISBN-13(EAN): 9780199655304 Издательство: Oxford Academ Рейтинг: Цена: 5384.00 р. Наличие на складе: Поставка под заказ.
Описание: Pharmaceutical Chemistry provides a wide-ranging overview of organic chemistry as applied to the study and practice of pharmacy. Drugs are simply chemicals, so to fully understand their manufacture, formulation, and the way they work in our bodies, an understanding of organic compounds and their reactions is essential.
Автор: Laszlo Endrenyi and Dr. Paul Declerck Название: Biosimilar Drug Product Development ISBN: 1498718795 ISBN-13(EAN): 9781498718790 Издательство: Taylor&Francis Рейтинг: Цена: 27562.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is also complicated and difficult. Biosimilar Drug Product Development presents current issues for the development of biosimilars and gives detailed reviews of its various stages and contributing factors as well as relevant regulatory pathways and pre- and post-approval issues.
Описание: Illustrates the use of systems such as in-process control, quality auditing, and specifications, stressing a troubleshooting, cost-effective approach to product packaging for maximized early lead time to the customer. Addressing the needs of the pharmaceutical industry, the approaches supplied are l
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