Principles of Parenteral Solution Validation —— A Practical Lifecycle Approach

----- 父母的原则解决方案验证:一个实际的生命周期方法

ISBN: 9780128094129 出版年：2019 页码：300 Academic Press_RM

Principles of Parenteral Solution Validation: A Practical Lifecycle Approach covers all aspects involved in the development and process validation of a parenteral product. By using a lifecycle approach, this book discusses the latest technology, compliance developments, and regulatory considerations and trends, from process design, to divesting. As part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin, this book incorporates numerous case studies and real-world examples that address timely problems and offer solutions to the daily challenges facing practitioners in this area.Discusses international and domestic regulatory considerations in every sectionFeatures callout boxes that contain points-of-interest for each segment of the audience so readers can quickly find their interests and needs Contains important topics, including risk management, the preparation and execution of properly designed studies, scale-up and technology transfer activities, problem-solving, and more