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Zokinvy
申请企业
EIGER BIOPHARMACEUTICALS INC
承诺描述
A thorough QT/QTc trial to evaluate the effect of lonafarnib on QT interval prolongation. Design and conduct the trial in accordance with the ICH E14 guidances for industry E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs (October 2015) and E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythimic DrugsQuestions and Answers (R3) (June 2017).