Книга "Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture" рассматривает концепцию "Quality by Design" (QbD) в различных этапах разработки нового лекарственного препарата. Книга предоставляет широкий обзор QbD и показывает, как концепции и анализ QbD способствуют разработке и производству высококачественных продуктов. QbD рассматривается как рамочная концепция для создания понимания процессов, для реализации надежных и эффективных производственных процессов и обеспечения научно обоснованного регулирования фармацевтической промышленности. Книга разделена на три основных раздела: первые шесть глав посвящены роли ключевых технологий, включая моделирование процессов, процессный аналитический контроль, автоматизированный процессный контроль и статистическую методологию в поддержке QbD и установлении связанного с ним дизайн-пространства. Второй раздел, состоящий из семи глав, представляет собой ряд тщательно разработанных кейс-стади, в которых используются инструменты и методологии, обсуждаемые в первом разделе, для поддержки конкретных разработок, связанных с QbD для лекарственных веществ и медикаментов. Последний раздел посвящен необходимости интегрированных инструментов и обзору состояния информационных технологий для систематического управления данными и знаниями в поддержку QbD и связанных деятельностей. Книга идеально подходит для практикующих специалистов, исследователей и аспирантов, занимающихся разработкой, исследованием или изучением нового лекарственного препарата и связанного с ним производственного процесса.
This book covers a wide range of Quality by design (QbD), encompassing all stages involved in pharmaceutical product development. It provides an overview of QbD principles and how they can be utilized in order to develop high quality product. From its introduction, this book demonstrates the benefits QbD has to offer, such as helping in building understanding of the manufacturing system, implementing robust manufacturing processes and contributing to the science-based control of pharmaceutical products. This book also covers how it is currently being applied in education programs within pharmaceutical industry as well.The book divides its contents into 3 sections: Chemistry/Pharmaceutical Sciences includes chapters about the role Key Technologies in QbD such as Process Modeling and Automated Process Control as well The Need for Integrated Tools and Systematic Data and Knowledge Management Reveals the Status of Information Technology Tools The latter two chapters cover the third sector of processing - solid liquid processing as well as provides a review of the various process models.
Электронная Книга «Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture» написана автором Группа авторов в году.
Минимальный возраст читателя: 0
Язык: Английский
ISBN: 9781119356165
Описание книги от Группа авторов
Covers a widespread view of Quality by Design (QbD) encompassing the many stages involved in the development of a new drug product. The book provides a broad view of Quality by Design (QbD) and shows how QbD concepts and analysis facilitate the development and manufacture of high quality products. QbD is seen as a framework for building process understanding, for implementing robust and effective manufacturing processes and provides the underpinnings for a science-based regulation of the pharmaceutical industry. Edited by the three renowned researchers in the field, Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture guides pharmaceutical engineers and scientists involved in product and process development, as well as teachers, on how to utilize QbD practices and applications effectively while complying with government regulations. The material is divided into three main sections: the first six chapters address the role of key technologies, including process modeling, process analytical technology, automated process control and statistical methodology in supporting QbD and establishing the associated design space. The second section consisting of seven chapters present a range of thoroughly developed case studies in which the tools and methodologies discussed in the first section are used to support specific drug substance and drug-product QbD related developments. The last section discussed the needs for integrated tools and reviews the status of information technology tools available for systematic data and knowledge management to support QbD and related activities. Highlights Demonstrates Quality by Design (QbD) concepts through concrete detailed industrial case studies involving of the use of best practices and assessment of regulatory implications Chapters are devoted to applications of QbD methodology in three main processing sectors—drug substance process development, oral drug product manufacture, parenteral product processing, and solid-liquid processing Reviews the spectrum of process model types and their relevance, the range of state-of-the-art real-time monitoring tools and chemometrics, and alternative automatic process control strategies and methods for both batch and continuous processes The role of the design space is demonstrated through specific examples and the importance of understanding the risk management aspects of design space definition is highlighted Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture is an ideal book for practitioners, researchers, and graduate students involved in the development, research, or studying of a new drug and its associated manufacturing process.
