Principles and Practices of Lyophilization in Product Development and Manufacturing, Jameel
Автор: Ward Kevin R., Matejtschuk Paul Название: Lyophilization of Pharmaceuticals and Biologicals: New Technologies and Approaches ISBN: 1493989278 ISBN-13(EAN): 9781493989270 Издательство: Springer Рейтинг: Цена: 16630.00 р. 23757.00-30% Наличие на складе: Есть (1 шт.) Описание: This detailed volume brings together leading practitioners in the freeze-drying community to address recent progress, not only in new analytical tools and applications of the data derived in cycle design but also in the manufacturing of lyophilized products in the healthcare sector - whether these be therapeutics, vaccines or diagnostic products - and indeed the equipment to deliver this scale of freeze-drying. Areas of focus include analytical and formulation issues, process monitoring and control, as well as post-lyophilization analysis. Written for the Methods in Pharmacology and Toxicology series, chapters include the type of expert advice that leads to superior results in the lab.
Authoritative and practical, Lyophilization of Pharmaceuticals and Biologicals: New Technologies and Approaches serves as an ideal guide for researchers working in or just seeking an update on this rapidly changing field.
Biopharmaceuticals, medicines made by or from living organisms (including cells from living organisms), are extremely effective in treating a broad range of diseases. Their importance to human health has grown significantly over the years as more biopharmaceutical products have entered the market, and now the biggest selling drugs in the world are biopharmaceuticals. Biopharmaceutical Manufacturing: Principles, Processes and Practices provides concise, comprehensive, and up-to-date coverage of biopharmaceutical manufacturing. Written in a clear and informal style, the content has been influenced by the authors’ substantial industry experience and teaching expertise. That expertise enables the authors to address the many questions posed over the years both by university students and professionals with experience in the field. Consequently, the book will appeal both to undergraduate or graduate students using it as a textbook and specialized industry practitioners seeking to understand the big picture of biopharmaceutical manufacturing. This book:
Название: Good Manufacturing Practices Pharma ISBN: 1498732062 ISBN-13(EAN): 9781498732062 Издательство: Taylor&Francis Рейтинг: Цена: 26796.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
This book provides insight into the world of pharmaceutical quality systems and the key elements that must be in place to change the business and organizational dynamics from task-oriented procedure-based cultures to truly integrated quality business systems that are self-detecting and correcting. Chapter flow has been changed to adopt a quality systems organization approach, and supporting chapters have been updated based on current hot topics including the impact of the worldwide supply chain complexity and current regulatory trends.
Key Features:
Presents insight into the world of pharmaceutical quality systems
Analyzes regulatory trends and expectations
Includes approaches and practices used in the industry to comply with regulatory requirements
Discusses recent worldwide supply chain issues
Delivers valuable information to a worldwide audience regarding the current GMP practices in the industry
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