Disproportionality Analysis

Disproportionality Analysis is a method used in pharmacovigilance to examine databases containing Individual Case Safety/Study Reports (ICSRs). This analysis involves screening for statistical associations between specific medical products and adverse events, with a focus on identifying cases where the observed frequency of these associations significantly differs from the expected frequency based on historical or background data. This approach helps to pinpoint potential safety concerns and patterns that may require further investigation and regulatory action.