Preemptive Pharmacovigilance — Three-Tier Signal Detection
Proactive safety signal detection beyond reactive PRR. Three tiers: Reactive (standard disproportionality), Predictive (severity-weighted PRR), Preemptive (Gibbs thermodynamic energy modeling). Plus t
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Reactive
Tier 1: Standard reactive signal detection from a 2x2 contingency table. Returns PRR, chi-squared, and detection verdict
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Predictive
Tier 2: Severity-weighted predictive detection. Multiplies PRR by seriousness omega weight (ICH E2A criteria). More seri
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Gibbs
Tier 3: Preemptive detection via Gibbs free energy thermodynamic model. Negative delta-G = spontaneous signal (drug-even
prrn
Evaluate
Full three-tier evaluation: runs reactive, predictive, AND preemptive detection in one call. Returns results from all ti
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Trajectory
Trajectory amplification: detect accelerating reporting trends using Hill curve amplification on time-series data. Repor
data
Severity
Get the severity weight (omega) for a seriousness level. Returns the ICH E2A-based weight used in predictive and preempt
seriousness
Noise
Noise floor correction: compute corrected signal by subtracting background noise and testing statistical significance.
observedbackground
Intervention
Model competitive inhibition intervention: compute residual signal after applying an intervention of given strength. Bas
signal_strengthintervention_strength
Required Strength
Compute the intervention strength needed to achieve a target signal reduction.
signal_strength
Omega Table
Reference table of all seriousness omega weights used in predictive and preemptive tiers.
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