生物制品监管基础：疫苗与生物技术药物

Rebecca Sheets | 2018 | ISBN: 0128092904 | English | 450 pages | PDF | 10 MB

Fundamentals of Biologicals Regulation: Vaccines and Biotechnology Medicines serves as an introduction to the international regulatory arena in which biologicals are developed and offers an overview of the processes and insight into the scientific concepts underpinning global regulations. This book will provide multiple levels of readership with guidance on basic concepts, a detailed look at regulatory challenges, and practical insight into how regulators consider regulatory science and regulatory process issues across various regions. With numerous case studies, learning activities, and real-world examples across several classes of biotechnological products, this book is a valuable and comprehensive resource for graduate students, professors, regulatory officials, and industry scientists working with biologicals.

• Provides a broad overview and introduction to the regulatory processes, from product development pathways, through clinical trials and product development stages and beyond • Includes FDA, EMA, ICH, and WHO recommendations and guidelines so readers can compare and contrast the different regulatory regions with their expectations and understand why they are different • Contains chapters on some of the exceptions to the process including how biosimilars and in vitro diagnostics are regulated • Includes numerous case studies, learning activities, and real-world examples across several classes of biotechnological products

生物制品监管基础：疫苗和生物技术药物为读者提供了一个了解国际监管领域的机会，在这里生物制品被开发，并概述了支撑全球法规的基本科学概念。本书将向不同层次的读者提供关于基本概念的指导，详细介绍了监管挑战，并提供了跨多个地区的监管科学和过程问题的实用见解。通过多种类别生物技术产品的案例研究、学习活动和实际例子，这本著作对于研究生学生、教授、监管官员以及从事生物制品工作的行业科学家来说是一项宝贵的综合资源。 • 提供对法规流程的广泛概述和介绍，从产品开发路径到临床试验及产品开发阶段，再到更多领域 • 包含FDA、EMA、ICH和WHO的建议与指导，以便读者可以比较不同地区的监管区域，并理解其期望为何不同 • 包括一些例外情况的章节，包括生物仿制药和体外诊断是如何被监管的 • 提供多种类别生物技术产品中的案例研究、学习活动及实际例子

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