作者
Zhihua Li, Gary R Mirams, Takashi Yoshinaga, Bradley J Ridder, Xiaomei Han, Janell E Chen, Norman L Stockbridge, Todd A Wisialowski, Bruce Damiano, Stefano Severi, Pierre Morissette, Peter R Kowey, Mark Holbrook, Godfrey Smith, Randall L Rasmusson, Michael Liu, Zhen Song, Zhilin Qu, Derek J Leishman, Jill Steidl‐Nichols, Blanca Rodriguez, Alfonso Bueno‐Orovio, Xin Zhou, Elisa Passini, Andrew G Edwards, Stefano Morotti, Haibo Ni, Eleonora Grandi, Colleen E Clancy, Jamie Vandenberg, Adam Hill, Mikiko Nakamura, Thomas Singer, Liudmila Polonchuk, Andrea Greiter‐Wilke, Ken Wang, Stephane Nave, Aaron Fullerton, Eric A Sobie, Michelangelo Paci, Flora Musuamba Tshinanu, David G Strauss
发表日期
2020/1
期刊
Clinical Pharmacology & Therapeutics
卷号
107
期号
1
页码范围
102-111
简介
This white paper presents principles for validating proarrhythmia risk prediction models for regulatory use as discussed at the In Silico Breakout Session of a Cardiac Safety Research Consortium/Health and Environmental Sciences Institute/US Food and Drug Administration–sponsored Think Tank Meeting on May 22, 2018. The meeting was convened to evaluate the progress in the development of a new cardiac safety paradigm, the Comprehensive in Vitro Proarrhythmia Assay (CiPA). The opinions regarding these principles reflect the collective views of those who participated in the discussion of this topic both at and after the breakout session. Although primarily discussed in the context of in silico models, these principles describe the interface between experimental input and model‐based interpretation and are intended to be general enough to be applied to other types of nonclinical models for proarrhythmia …
学术搜索中的文章
Z Li, GR Mirams, T Yoshinaga, BJ Ridder, X Han… - Clinical Pharmacology & Therapeutics, 2020