Method and system for reevaluating safety of drug after appearance on market

2015 
The invention discloses a method and a system for reevaluating the safety of a drug after appearance on the market. The method comprises the following steps of: determining a studied drug; setting a sensitive signal; determining a case collection quantity; acquiring data and establishing a database; processing the data and carrying out data statistics; establishing a logistic model and determining associated risk factors; and predicting the safety for applying the drug to a patient. The system comprises: an input module; an output module; a storage module; a commonly-used drug database; an international disease classification standard database; a drug classification database; an adverse drug reaction term set database; a signal capture module; a data processing and statistic module; and a safety reevaluating module and a safety predicting module for the drug after appearance on the market. The method and the system can provide a basis for clinical rational drug administration and risk management after the drug appears on the market, can provide a scientific and reasonable analysis platform for establishing the safety evaluation after the drug appears on the market, and are reliable in principle, timely and accurate in data capture, flexible and convenient in application operation, and good in visibility.
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