heor-agent-mcp 1.2.2 → 1.3.1

package/README.md

@@ -70,7 +70,7 @@ Add to your MCP configuration:
 
 ---
 
-## Tools (21)
+## Tools (22)
 
 | Tool | Purpose |
 |------|---------|
@@ -368,7 +368,7 @@ A companion chat interface is available at:
 
 **https://web-michael-ns-projects.vercel.app**
 
-- Chat with Claude Sonnet 4.6 + all 21 HEOR tools
+- Chat with Claude Sonnet 4.6 + all 22 HEOR tools
 - **BYOK (Bring Your Own Key)** — paste your Anthropic API key in the settings; it stays in your browser's localStorage and is never stored on our servers
 - Markdown rendering with styled tables, tool call cards with live progress timers, and theme-aware mermaid network diagrams
 - 12 example prompts covering literature search, CEA, BIA, NMA, ITC feasibility, RoB, EQ-5D 5L, EU JCA dossiers

package/dist/pv/decisionTree.d.ts

@@ -17,6 +17,8 @@ interface Decision {
     primary_category: PvCategory;
     alternatives: PvCategory[];
     rationale: string;
+    /** Optional advisory warnings surfaced from edge cases — handler attaches to audit. */
+    advisory_warnings?: string[];
 }
 export declare function classifyPv(input: PvClassifyInput): Decision;
 export {};

package/dist/pv/decisionTree.d.ts.map

@@ -1 +1 @@
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+{"version":3,"file":"decisionTree.d.ts","sourceRoot":"","sources":["../../src/pv/decisionTree.ts"],"names":[],"mappings":"AAAA;;;;;;;;;;;;;GAaG;AACH,OAAO,KAAK,EAAE,UAAU,EAAE,eAAe,EAAE,MAAM,YAAY,CAAC;AAE9D,UAAU,QAAQ;IAChB,gBAAgB,EAAE,UAAU,CAAC;IAC7B,YAAY,EAAE,UAAU,EAAE,CAAC;IAC3B,SAAS,EAAE,MAAM,CAAC;IAClB,uFAAuF;IACvF,iBAAiB,CAAC,EAAE,MAAM,EAAE,CAAC;CAC9B;AAED,wBAAgB,UAAU,CAAC,KAAK,EAAE,eAAe,GAAG,QAAQ,CAmI3D"}

package/dist/pv/decisionTree.js

@@ -1,39 +1,75 @@
 export function classifyPv(input) {
-    // 1. Pre-authorisation: never PASS — characterise via ICH E2E plan.
+    // 1. Pre-authorisation: never PASS — characterise via ICH E2E plan
+    //    (which is an ICH guideline, NOT a GVP module). The plan informs
+    //    the initial RMP that's submitted at MA grant under GVP Module V.
     if (input.regulatory_context === "pre_authorisation") {
         return withPregnancyOverride(input, {
             primary_category: "ICH_E2E_pharmacovigilance_plan",
             alternatives: [],
-            rationale: "Study is pre-authorisation. PASS designations require an existing marketing authorisation (Article 107a). Pharmacovigilance planning at this stage falls under ICH E2E and feeds the initial RMP at MAA submission.",
+            rationale: "Study is pre-authorisation. PASS designations require an existing marketing authorisation (Article 107a). Pharmacovigilance planning at this stage falls under ICH E2E — note that ICH E2E is a standalone ICH guideline, not a GVP module; the GVP Module V reference reflects the downstream RMP that the E2E plan informs at MAA submission, not a direct mapping.",
         });
     }
     // 2. Spontaneous reports stand alone — Module VI baseline obligation.
+    //    imposed_by_authority is contradictory here (spontaneous reporting
+    //    is an inherent obligation, not something an authority can impose
+    //    as a study) — surface a warning rather than silently dropping the
+    //    flag.
     if (input.study_design === "spontaneous_reports") {
+        const warnings = input.imposed_by_authority
+            ? [
+                "Contradictory inputs: study_design='spontaneous_reports' AND imposed_by_authority=true. Spontaneous adverse-event reporting is an inherent PV obligation under GVP Module VI, not a designed study an authority can impose. The imposed_by_authority flag has been ignored.",
+            ]
+            : undefined;
         return withPregnancyOverride(input, {
             primary_category: "spontaneous_reporting_only",
             alternatives: [],
             rationale: "Spontaneous adverse-event reporting is the baseline PV obligation under GVP Module VI, not a designed study. Categorised as spontaneous_reporting_only.",
+            advisory_warnings: warnings,
         });
     }
-    // 3. RMP commitment context → Annex 4 listed study.
+    // 3. Imposed PASS takes precedence over plain RMP_Annex_4_study —
+    //    Article 107n imposition outranks Annex 4 listing. The Annex 4
+    //    listing is then a downstream consequence of the imposition.
+    if (input.imposed_by_authority) {
+        const warnings = [];
+        if ((input.regulatory_context === "conditional_approval" ||
+            input.regulatory_context === "accelerated_approval") &&
+            !input.imposed_by_authority) {
+            // dead branch (imposed=true above) — guarded for clarity if reordered
+        }
+        return withPregnancyOverride(input, {
+            primary_category: "PASS_imposed",
+            alternatives: input.regulatory_context === "rmp_commitment"
+                ? ["RMP_Annex_4_study"]
+                : ["RMP_Annex_4_study"],
+            rationale: input.regulatory_context === "rmp_commitment"
+                ? "Authority-imposed obligation that is also tracked as an RMP Annex 4 commitment. Article 107n imposition is the primary classification — the Annex 4 listing is a consequence, not the primary route. Falls under GVP Module VIII (PASS imposed); PRAC pre-review of the protocol is required."
+                : "Authority-imposed obligation in a post-authorisation context (Article 107n). Falls under GVP Module VIII as a Post-Authorisation Safety Study (imposed). PRAC pre-review of the protocol is required.",
+            advisory_warnings: warnings.length > 0 ? warnings : undefined,
+        });
+    }
+    // 4. RMP commitment context → Annex 4 listed study (when not imposed).
     if (input.regulatory_context === "rmp_commitment") {
-        const alts = input.imposed_by_authority
-            ? ["PASS_imposed"]
-            : ["PASS_voluntary"];
         return withPregnancyOverride(input, {
             primary_category: "RMP_Annex_4_study",
-            alternatives: alts,
+            alternatives: ["PASS_voluntary"],
             rationale: "Study is an explicit RMP commitment, listed in RMP Annex 4 with milestone tracking. Per EMA GVP Module V.",
         });
     }
-    // 4. Imposed PASS — applies to conditional, accelerated, and standard
-    //    post-authorisation contexts when the authority has imposed the
-    //    obligation (Article 107n / 107a).
-    if (input.imposed_by_authority) {
+    // 4a. Conditional / accelerated approval WITHOUT imposed_by_authority —
+    //     warn about Specific Obligations (CMA SOBs) per Article 14-a.
+    //     Falling through to objective-based classification but the user
+    //     should confirm whether the obligation is actually imposed.
+    if ((input.regulatory_context === "conditional_approval" ||
+        input.regulatory_context === "accelerated_approval") &&
+        !input.imposed_by_authority) {
+        const out = classifyByObjective(input);
         return withPregnancyOverride(input, {
-            primary_category: "PASS_imposed",
-            alternatives: ["RMP_Annex_4_study"],
-            rationale: "Authority-imposed obligation in a post-authorisation context (Article 107n). Falls under GVP Module VIII as a Post-Authorisation Safety Study (imposed). PRAC pre-review of the protocol is required.",
+            ...out,
+            advisory_warnings: [
+                ...(out.advisory_warnings ?? []),
+                `regulatory_context='${input.regulatory_context}' typically carries Specific Obligations (CMA Article 14-a / accelerated-approval SOBs) that function as an imposed PASS even without imposed_by_authority=true. Confirm SOB status with regulatory affairs; if confirmed, re-run with imposed_by_authority=true to get the correct PASS_imposed classification + Module VIII PRAC pre-review obligations.`,
+            ],
         });
     }
     // 5. Otherwise classify by primary objective + study design.
@@ -82,6 +118,7 @@ function withPregnancyOverride(input, decision) {
             alternatives: ["pregnancy_registry"],
             rationale: decision.rationale +
                 " Pregnancy population: a pregnancy registry will be required as a post-authorisation commitment per ICH E2E and EMA pregnancy-registry guidance.",
+            advisory_warnings: decision.advisory_warnings,
         };
     }
     if (decision.primary_category === "pregnancy_registry")
@@ -94,6 +131,47 @@ function withPregnancyOverride(input, decision) {
         rationale: "Pregnancy population in scope → pregnancy registry takes priority over the primary classification. " +
             decision.rationale +
             " The original classification is retained as an alternative for protocol-design context.",
+        advisory_warnings: decision.advisory_warnings,
     };
 }
+/**
+ * Pure classification by primary_objective. Extracted so the
+ * conditional_approval / accelerated_approval branch can reuse it without
+ * duplicating the switch.
+ */
+function classifyByObjective(input) {
+    switch (input.primary_objective) {
+        case "safety":
+            return {
+                primary_category: "PASS_voluntary",
+                alternatives: ["active_surveillance_registry"],
+                rationale: "Safety-objective post-authorisation study without an imposed obligation → voluntary PASS under GVP Module VIII.",
+            };
+        case "efficacy":
+        case "effectiveness":
+            return {
+                primary_category: "PAES",
+                alternatives: ["PASS_voluntary"],
+                rationale: "Effectiveness/efficacy-objective post-authorisation study → Post-Authorisation Efficacy Study (PAES).",
+            };
+        case "drug_utilization":
+            return {
+                primary_category: "DUS",
+                alternatives: ["PASS_voluntary"],
+                rationale: "Drug utilisation objective → DUS under GVP Module VIII Addendum I.",
+            };
+        case "natural_history":
+            return {
+                primary_category: "active_surveillance_registry",
+                alternatives: ["PASS_voluntary"],
+                rationale: "Natural history / disease epidemiology objective → active surveillance registry.",
+            };
+        case "risk_minimisation_evaluation":
+            return {
+                primary_category: "PASS_voluntary",
+                alternatives: ["DUS"],
+                rationale: "Evaluation of risk-minimisation measure effectiveness → categorised as PASS (voluntary unless imposed).",
+            };
+    }
+}
 //# sourceMappingURL=decisionTree.js.map

package/dist/pv/decisionTree.js.map

@@ -1 +1 @@
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package/dist/pv/gvpModules.d.ts

@@ -9,7 +9,8 @@ import type { GvpModule, PvCategory } from "./types.js";
 export declare const GVP_REVISION: "rev_4";
 interface CategoryMapping {
     gvp_module: GvpModule;
-    encepp_protocol_template?: string;
+    /** Plain-language ENCePP category label — NOT a registered protocol ID. */
+    encepp_study_category?: string;
     rmp_implications: string[];
     fda_analogue?: string;
     submission_obligations: string[];

package/dist/pv/gvpModules.d.ts.map

@@ -1 +1 @@
-{"version":3,"file":"gvpModules.d.ts","sourceRoot":"","sources":["../../src/pv/gvpModules.ts"],"names":[],"mappings":"AAAA;;;;;;GAMG;AACH,OAAO,KAAK,EAAE,SAAS,EAAE,UAAU,EAAE,MAAM,YAAY,CAAC;AAExD,eAAO,MAAM,YAAY,EAAG,OAAgB,CAAC;AAE7C,UAAU,eAAe;IACvB,UAAU,EAAE,SAAS,CAAC;IACtB,wBAAwB,CAAC,EAAE,MAAM,CAAC;IAClC,gBAAgB,EAAE,MAAM,EAAE,CAAC;IAC3B,YAAY,CAAC,EAAE,MAAM,CAAC;IACtB,sBAAsB,EAAE,MAAM,EAAE,CAAC;CAClC;AAED,eAAO,MAAM,gBAAgB,EAAE,MAAM,CAAC,UAAU,EAAE,eAAe,CA2HhE,CAAC;AAEF,wBAAgB,MAAM,CAAC,QAAQ,EAAE,UAAU,GAAG,eAAe,CAE5D"}
+{"version":3,"file":"gvpModules.d.ts","sourceRoot":"","sources":["../../src/pv/gvpModules.ts"],"names":[],"mappings":"AAAA;;;;;;GAMG;AACH,OAAO,KAAK,EAAE,SAAS,EAAE,UAAU,EAAE,MAAM,YAAY,CAAC;AAExD,eAAO,MAAM,YAAY,EAAG,OAAgB,CAAC;AAE7C,UAAU,eAAe;IACvB,UAAU,EAAE,SAAS,CAAC;IACtB,2EAA2E;IAC3E,qBAAqB,CAAC,EAAE,MAAM,CAAC;IAC/B,gBAAgB,EAAE,MAAM,EAAE,CAAC;IAC3B,YAAY,CAAC,EAAE,MAAM,CAAC;IACtB,sBAAsB,EAAE,MAAM,EAAE,CAAC;CAClC;AAED,eAAO,MAAM,gBAAgB,EAAE,MAAM,CAAC,UAAU,EAAE,eAAe,CA2HhE,CAAC;AAEF,wBAAgB,MAAM,CAAC,QAAQ,EAAE,UAAU,GAAG,eAAe,CAE5D"}

package/dist/pv/gvpModules.js

@@ -2,7 +2,7 @@ export const GVP_REVISION = "rev_4";
 export const CATEGORY_MAPPING = {
     PASS_imposed: {
         gvp_module: "VIII",
-        encepp_protocol_template: "ENCePP-PASS-001",
+        encepp_study_category: "PASS — post-authorisation safety study (imposed, GVP Module VIII). Use the ENCePP Code of Conduct checklist for protocol structure",
         rmp_implications: [
             "Update RMP Part III (PV Plan) to list this study as an imposed PASS.",
             "Annex 4 of the RMP must reference the protocol and timelines.",
@@ -16,7 +16,7 @@ export const CATEGORY_MAPPING = {
     },
     PASS_voluntary: {
         gvp_module: "VIII",
-        encepp_protocol_template: "ENCePP-PASS-002",
+        encepp_study_category: "PASS — post-authorisation safety study (voluntary, GVP Module VIII). ENCePP registration in EUPAS encouraged",
         rmp_implications: [
             "Document study as a voluntary PASS in RMP Part III.",
             "No PRAC pre-approval required; encouraged ENCePP registration.",
@@ -29,7 +29,7 @@ export const CATEGORY_MAPPING = {
     },
     PAES: {
         gvp_module: "VIII",
-        encepp_protocol_template: "ENCePP-PAES-001",
+        encepp_study_category: "PAES — post-authorisation efficacy study (GVP Module VIII)",
         rmp_implications: [
             "PAES results may trigger MA variation if effectiveness diverges from MA assumptions.",
         ],
@@ -41,7 +41,7 @@ export const CATEGORY_MAPPING = {
     },
     RMP_Annex_4_study: {
         gvp_module: "V",
-        encepp_protocol_template: "ENCePP-RMP-001",
+        encepp_study_category: "RMP Annex 4 study (GVP Module V)",
         rmp_implications: [
             "Listed in RMP Annex 4 with study ID, status, milestone dates.",
             "Study completion is a tracked RMP commitment.",
@@ -54,7 +54,7 @@ export const CATEGORY_MAPPING = {
     },
     DUS: {
         gvp_module: "VIII_Addendum_I",
-        encepp_protocol_template: "ENCePP-DUS-001",
+        encepp_study_category: "DUS — drug utilisation study (GVP Module VIII Addendum I)",
         rmp_implications: [
             "DUS may be referenced in RMP Part III for risk minimisation effectiveness.",
         ],
@@ -66,7 +66,7 @@ export const CATEGORY_MAPPING = {
     },
     active_surveillance_registry: {
         gvp_module: "VIII",
-        encepp_protocol_template: "ENCePP-REG-001",
+        encepp_study_category: "Active surveillance registry (GVP Module VIII)",
         rmp_implications: [
             "Registry serves as data source for ongoing PV signal detection in RMP Part III.",
         ],
@@ -78,7 +78,7 @@ export const CATEGORY_MAPPING = {
     },
     pregnancy_registry: {
         gvp_module: "VIII",
-        encepp_protocol_template: "ENCePP-PREG-001",
+        encepp_study_category: "Pregnancy registry (GVP Module VIII; refer to GVP Considerations P.III)",
         rmp_implications: [
             "Pregnancy registry is a standard RMP commitment for teratogenic-risk drugs (Annex 4).",
             "Outcomes feed into the Pregnancy section of every PSUR.",

package/dist/pv/gvpModules.js.map

@@ -1 +1 @@
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package/dist/pv/signalDecision.d.ts

@@ -0,0 +1,54 @@
+/**
+ * Pure decision logic for pv_signal_workflow. Given disproportionality
+ * statistics, decide the signal verdict per EMA GVP Module IX rev 2 +
+ * common Bayesian / frequentist thresholds.
+ */
+import { type CaseCounts } from "./signalStatistics.js";
+export type SignalVerdict = "no_signal" | "strengthening_signal" | "confirmed_signal" | "previously_known_signal" | "refuted_signal";
+export interface SignalThresholds {
+    /** PRR ≥ this AND chi-squared ≥ chi2 AND N ≥ n_min triggers PRR */
+    prr_min: number;
+    ror_min: number;
+    ic025_min: number;
+    eb05_min: number;
+    chi2_min: number;
+    n_min: number;
+}
+export interface SignalStatisticsResult {
+    prr: {
+        value: number;
+        ci_low: number;
+        ci_high: number;
+        threshold_met: boolean;
+    };
+    ror: {
+        value: number;
+        ci_low: number;
+        ci_high: number;
+        threshold_met: boolean;
+    };
+    ic: {
+        value: number;
+        ic025: number;
+        threshold_met: boolean;
+    };
+    mgps: {
+        ebgm: number;
+        eb05: number;
+        eb95: number;
+        threshold_met: boolean;
+    };
+    chi_squared: number;
+    n_cases: number;
+    thresholds_used: "default" | "serious";
+}
+export declare function computeAllStats(counts: CaseCounts, outcomeSerious: boolean): SignalStatisticsResult;
+export interface SignalDecisionInput {
+    stats: SignalStatisticsResult;
+    prior_known_signals: string[];
+    outcome_serious: boolean;
+    reported_event?: string;
+    thresholds?: SignalThresholds;
+}
+export declare function decideVerdict(input: SignalDecisionInput): SignalVerdict;
+//# sourceMappingURL=signalDecision.d.ts.map

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package/dist/pv/signalDecision.js

@@ -0,0 +1,115 @@
+/**
+ * Pure decision logic for pv_signal_workflow. Given disproportionality
+ * statistics, decide the signal verdict per EMA GVP Module IX rev 2 +
+ * common Bayesian / frequentist thresholds.
+ */
+import { computeIc, computeMgps, computePrr, computeRor, } from "./signalStatistics.js";
+const DEFAULT_THRESHOLDS = {
+    prr_min: 2.0,
+    ror_min: 2.0,
+    ic025_min: 0.0,
+    eb05_min: 2.0,
+    chi2_min: 4.0,
+    n_min: 3,
+};
+/** Lower thresholds when the AE is serious (fatal / life-threatening / hospitalisation). */
+const SERIOUS_THRESHOLDS = {
+    prr_min: 1.5,
+    ror_min: 1.5,
+    ic025_min: 0.0,
+    eb05_min: 1.5,
+    chi2_min: 4.0,
+    n_min: 3,
+};
+export function computeAllStats(counts, outcomeSerious) {
+    const T = outcomeSerious ? SERIOUS_THRESHOLDS : DEFAULT_THRESHOLDS;
+    const prr = computePrr(counts);
+    const ror = computeRor(counts);
+    const ic = computeIc(counts);
+    const mgps = computeMgps(counts);
+    return {
+        prr: {
+            value: prr.value,
+            ci_low: prr.ci_low,
+            ci_high: prr.ci_high,
+            threshold_met: prr.value >= T.prr_min &&
+                prr.chi_squared >= T.chi2_min &&
+                counts.drug_event >= T.n_min,
+        },
+        ror: {
+            value: ror.value,
+            ci_low: ror.ci_low,
+            ci_high: ror.ci_high,
+            threshold_met: ror.value >= T.ror_min && counts.drug_event >= T.n_min,
+        },
+        ic: {
+            value: ic.value,
+            ic025: ic.ic025,
+            threshold_met: ic.ic025 > T.ic025_min,
+        },
+        mgps: {
+            ebgm: mgps.ebgm,
+            eb05: mgps.eb05,
+            eb95: mgps.eb95,
+            threshold_met: mgps.eb05 >= T.eb05_min,
+        },
+        chi_squared: prr.chi_squared,
+        n_cases: counts.drug_event,
+        thresholds_used: outcomeSerious ? "serious" : "default",
+    };
+}
+/**
+ * Returns true if `reported_event` matches any string in `prior_known_signals`
+ * by case-insensitive substring containment in either direction. Avoids both
+ * false negatives ("severe lactic acidosis" should match prior "lactic
+ * acidosis") and false positives ("myocardial infarction" must NOT match
+ * prior "lactic acidosis" just because both are non-empty strings).
+ */
+function reportedEventMatchesPriorSignal(reportedEvent, priorKnownSignals) {
+    if (!reportedEvent)
+        return false;
+    if (!priorKnownSignals || priorKnownSignals.length === 0)
+        return false;
+    const ev = reportedEvent.trim().toLowerCase();
+    if (!ev)
+        return false;
+    for (const prior of priorKnownSignals) {
+        const p = prior.trim().toLowerCase();
+        if (!p)
+            continue;
+        if (ev.includes(p) || p.includes(ev))
+            return true;
+    }
+    return false;
+}
+export function decideVerdict(input) {
+    const triggers = [
+        input.stats.prr.threshold_met,
+        input.stats.ror.threshold_met,
+        input.stats.ic.threshold_met,
+        input.stats.mgps.threshold_met,
+    ].filter(Boolean).length;
+    // Previously-known classification fires only when the SPECIFIC reported
+    // event matches one of the prior known signals. Bare "prior_known_signals
+    // is non-empty" is NOT sufficient — that would suppress new signals for
+    // any drug with any known signal in its RMP.
+    if (triggers >= 2 &&
+        reportedEventMatchesPriorSignal(input.reported_event, input.prior_known_signals)) {
+        return "previously_known_signal";
+    }
+    // Refuted: all methods well below threshold AND N is reasonably large
+    if (triggers === 0 &&
+        input.stats.n_cases >= 10 &&
+        input.stats.prr.value < 0.5) {
+        return "refuted_signal";
+    }
+    if (triggers === 0)
+        return "no_signal";
+    if (triggers >= 2 &&
+        input.stats.n_cases >= 3 &&
+        input.stats.chi_squared >= 4) {
+        return "confirmed_signal";
+    }
+    return "strengthening_signal";
+}
+//# sourceMappingURL=signalDecision.js.map

package/dist/pv/signalDecision.js.map

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package/dist/pv/signalStatistics.d.ts

@@ -0,0 +1,67 @@
+/**
+ * Disproportionality statistics for pharmacovigilance signal detection.
+ * Pure math, no I/O.
+ *
+ * Implements:
+ *   - PRR (Proportional Reporting Ratio) — Evans 2001
+ *   - ROR (Reporting Odds Ratio) — van Puijenbroek 2002
+ *   - IC (Information Component, BCPNN posterior) — Bate 1998 / Norén 2006
+ *   - MGPS (Multi-item Gamma-Poisson Shrinker) — DuMouchel 1999, with EBGM
+ *     and EB05/EB95 via gamma-Poisson shrinkage
+ *
+ * 2x2 table convention:
+ *               event    not-event
+ *   drug:         a         b           drug_total = a + b
+ *   not-drug:     c         d           not-drug-total = c + d
+ *   event_total = a + c; grand_total = a+b+c+d
+ *
+ * Inputs to the public functions are the four cell counts.
+ */
+export interface CaseCounts {
+    drug_event: number;
+    drug_total: number;
+    event_total: number;
+    grand_total: number;
+}
+/** PRR per Evans 2001. Two-sided 95% CI on log scale. */
+export declare function computePrr(counts: CaseCounts): {
+    value: number;
+    ci_low: number;
+    ci_high: number;
+    chi_squared: number;
+};
+/** ROR per van Puijenbroek 2002. Two-sided 95% CI on log scale. */
+export declare function computeRor(counts: CaseCounts): {
+    value: number;
+    ci_low: number;
+    ci_high: number;
+};
+/**
+ * IC (Information Component) per Bate 1998 / Norén 2006 BCPNN.
+ *   IC = log2(P(drug, event) / (P(drug) * P(event)))
+ * with shrinkage so IC values for low-N pairs shrink toward 0.
+ * IC025 is the 2.5th percentile of the posterior distribution (lower 95% CI).
+ */
+export declare function computeIc(counts: CaseCounts): {
+    value: number;
+    ic025: number;
+};
+/**
+ * MGPS (Multi-item Gamma-Poisson Shrinker) per DuMouchel 1999.
+ * EBGM = empirical Bayes geometric mean of the relative reporting ratio,
+ * with gamma-Poisson shrinkage that pulls EBGM toward 1 when N is small.
+ *
+ * Simplified single-stratum implementation: prior alpha=beta=0.5 (Jeffreys).
+ * EB05 / EB95 are 5th / 95th percentiles of the posterior gamma
+ * distribution, approximated via the Wilson-Hilferty cube-root transformation.
+ *
+ * Suitable for educational / first-pass screening use; matches FDA-Sentinel
+ * shape but uses single-stratum (not stratified) shrinkage. Stratification
+ * by sex / age can be added in a future revision.
+ */
+export declare function computeMgps(counts: CaseCounts): {
+    ebgm: number;
+    eb05: number;
+    eb95: number;
+};
+//# sourceMappingURL=signalStatistics.d.ts.map

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