The invention belongs to the technical field of
drug safety
pharmacology, and particularly relates to an
hERG margin automatic data calculation method and
system. The method comprises the following steps: step 1, calculating the statistical magnitude of
hERG IC50 of a
drug to be analyzed, wherein the statistical magnitude comprises a sample size, an arithmetic mean value, a
lower limit and an upper limit of a 95%
confidence interval, and a standard deviation; step 2, taking the statistics obtained in the step 1 as basic data, generating probability distribution of key parameters through Monte Carlo
simulation, and calculating distribution of safety windows; and step 3, integrating data of all drugs to be analyzed, and obtaining overall safety window
estimation through meta-analysis. The invention further provides a
system for implementing the method. The method has the advantages of high efficiency, accuracy and accurate personalized calculation for special drugs, provides more scientific and reliable
technical support for
hERG safety window calculation and
risk assessment, and has a good application prospect.