Chinese Journal of Pharmacovigilance ›› 2017, Vol. 14 ›› Issue (6): 350-352.

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Application of Time-to-onset in Drug Safety Surveillance

YAN Xin-yuan1,2, WANG Yin-cheng1,2, ZHANG Tian-yi1, YE Xiao-fei1, HOU Yong-fang3, WU Gui-zhi3, HE Jia1,*   

  1. 1 Department of Health Statistics, Faculty of Health Service, Second Military Medical University, Shanghai 200433, China;
    2 Undergraduate Student, Faculty of Health Service, Second Military Medical University, Shanghai 200433, China;
    3 Center for Drug Reevaluation,CFDA, Beijing 100045, China
  • Received:2017-05-17 Revised:2017-08-17 Online:2017-06-20 Published:2017-08-17

Abstract: Objective Disproportionality analysis is the main method for signal detection and disproportionality analysis is based on the observed and expected values. Recently, time-to-onset (TTO) has been proposed as an effective tool in the adverse drug reactions surveillance. In this study, we aimed to introduce the principle and application of TTO method. Methods We discussed the theory, characteristic, signal detection performance of TTO method through literature review. Results TTO method has played role in signal detection, however, the performance result differed in different studies. Conclusion TTO method could act as an important complementary tool of disproportionality analysis for signal detection.

Key words: time-to-onset, adverse drug reaction, signal detection, disproportionality analysis

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