Case Studies in the Development of Drug Substance Control Strategies

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• 作者：Nicholas M. Thomson ; Robert Singer ; Kevin D. Seibert ; Carla V. Luciani ; Sushil Srivastava ; William F. Kiesman ; Erwin A. Irdam ; John V. Lepore ; Luke Schenck
• 刊名：Organic Process Research & Development
• 出版年：2015
• 出版时间：August 21, 2015
• 年：2015
• 卷：19
• 期：8
• 页码：935-948
• 全文大小：604K
• ISSN：1520-586X

文摘

A series of case histories from IQ consortium member companies are presented in order to exemplify many of the different elements of drug substance control strategies that are required in order to ensure process performance and product quality. Control through process, method, and/or model design can combine to form a holistic control strategy that effectively manages risk and assures quality for the patient. A typical drug substance control strategy overview is presented, along with a number of detailed case histories that aim to demonstrate the use of process design and the development of methods and modeling to ensure control of critical quality attributes where appropriate, whether in the final drug substance or through upstream controls.