Progress and thinking of signal detection methodology on post-marketing adverse drug reaction surveillance
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R994.11

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Supported by National Natural Science Foundation of China (82073671), Fund for Leading Talents of Shanghai Three-Year Action Plan for Public Health System Construction (GWV-10.2-XD22), Discipline Construction Program of Shanghai Three-Year Action Plan for Public Health System Construction (GWV-10.1-XK05), and Shuangzhong Construction Project of PLA-03.

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    Abstract:

    A large number of tragic drug-induced events worldwide have warned the necessity to pay attention to the safety of drugs. Drug regulatory authorities and marketing license holders are obliged to collect information on adverse drug reactions as early as possible and develop different risk management plans for different drugs to maximize the safety of drug users. In the whole life cycle management of drugs, signal detection is an important part of post-marketing safety monitoring. This paper introduces the basic principle of disproportionality analysis used in post-marketing adverse drug reaction surveillance and potential biases and bias control methods in data analysis, and discusses machine learning method for signal detection and the standardization of signal detection report, so as to improve the accuracy and timeliness of signal detection.

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History
  • Received:December 27,2021
  • Revised:January 17,2022
  • Adopted:
  • Online: March 30,2022
  • Published:
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