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.
Processing and Development of Polysaccharide-Based Biopolymers for Packaging Applications presents the latest cutting-edge research into the processing and utilization of bio-based polymers for packaging applications, covering materials derived from polysaccharides, polylactic acid (PLA), polyhydroxyalkanoates (PHAs), polybutylene and bio-polyethylene. The book also covers the principles of biopolymer plasticization, experimental and modeling techniques, the use of nanotechnology, and key advances relating to biopolymer-based packaging, including anti-microbials, anti-oxidative agents, and modified atmosphere packaging (MAP).
Development of Packaging and Products for Use in Microwave Ovens, Second Edition, supports the efficient design of microwaveable food products and packaging materials, explaining all essential aspects in a detailed and systematic way. This new edition reviews recent developments and the latest cutting-edge technology, including new materials and package formats, new ideas for product development, and new information on developments in microwave technology. Sections cover the effect of food dielectric properties and heating uniformity, microwave packaging materials, product development, food, packaging, oven safety, and the computer modelling of microwave products and active packaging.
Written by a distinguished team of international contributors, this book is not only a valuable resource for engineers, manufacturers and product developers in the food and packaging industries, but also a great research tool for industrial R&D and academia.
Описание: Addressing a significant need by describing the science and process involved to develop biosimilars of monoclonal antibody (mAb) drugs, this book covers all aspects of biosimilar development: preclinical, clinical, regulatory, manufacturing.
Автор: Laszlo Endrenyi and Dr. Paul Declerck Название: Biosimilar Drug Product Development ISBN: 1498718795 ISBN-13(EAN): 9781498718790 Издательство: Taylor&Francis Рейтинг: Цена: 29093.00 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.
Автор: Lee, Stan;Robinson, Graham (both of Zeneca Pharmac Название: Process Development: Fine Chemicals from Grams to Kilograms ISBN: 0198558244 ISBN-13(EAN): 9780198558248 Издательство: Oxford Academ Рейтинг: Цена: 5911.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Process development bridges the gap between the laboratory synthesis of an organic compound and its industrial manufacture on a large scale. This book uses real examples to show the range of problems which may be encountered in scaling up chemical syntheses and the ways in which they may be overcome.
Описание: Here is a practical guide that not only presents insights into the organization and management of the disciplines involved in chemical process development but also provides basic knowledge of these disciplines, enabling process development practitioners to recognize and assimilate them in their work.
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