Managing uncertainty: A perspective on risk pertaining to product quality attributes as they bear on immunogenicity of therapeutic proteins.
Managing uncertainty: A perspective on risk pertaining to product quality attributes as they bear on immunogenicity of therapeutic proteins.
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DOI：
10.1002/jps.23244
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发表时间：
2012-10-01
影响因子：
3.8
通讯作者：
Cherney, Barry W.
中科院分区：
文献类型：
--
作者：
Rosenberg, Amy S.;Verthelyi, Daniela;Cherney, Barry W.
本文讨论的关键问题是，行业和监管机构应如何管理产品质量属性对患者造成的不良事件风险，临床和/或非临床研究的大量证据支持其作为风险，但该属性引起临床不良事件的概率不确定。我们在此提供了我们对原则的看法，这些原则可用于确定当怀疑质量属性对安全性和/或有效性的影响但不确定时，控制质量属性的必要性和方式。作为一个例子，我们使用了由治疗性蛋白质中的亚可见蛋白质颗粒引起的对蛋白质治疗剂的免疫应答的风险。(C)2012 Wiley Periodicals，Inc.和American Pharmacologist Association J Pharm Sci 101：35603567，2012
The critical question addressed in this paper regards how industry and regulatory agencies should manage the risk of adverse events to patients posed by product quality attributes for which a preponderance of evidence from clinical and/or non-clinical studies supports it as a risk, but for which the probability of clinical adverse events arising from the attribute is uncertain. We here provide our perspective on the principles that can be applied to determine the need for and the manner in which to control quality attributes when their impact on safety and/or efficacy is suspected, but uncertain. As an example, we use the risk of immune responses to protein therapeutics posed by sub-visible protein particulates in therapeutic proteins. (C) 2012 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 101:35603567, 2012