ActivityPrescriptionChecker
Activity Prescription
Activity Prescription Checker — Radiopharmaceutical Therapy Dose Verification (EMA, SNMMI) ℹ️ The utility checks dose per kg body weight, renal function (GFR), cumulative dose, and minimum cycle intervals. ℹ️ Does not use machine learning — clinical protocol rules only (Lu-177, Ac-225). ⚠️ Critical for theranostics! Dose calculation errors lead to nephrotoxicity or treatment inefficacy. Strict renal function control is mandatory! Usage: ActivityPrescriptionChecker.exe → demo mode (console output) ActivityPrescriptionChecker.exe input.csv output.json → evaluate your data Input format: PatientID,WeightKg,HeightCm,GFR_MLMin,PrescribedActivityMBq,Radionuclide,CycleNumber,PreviousDoseMBq,LastTreatmentDate Example (CycleNumber > 1 requires LastTreatmentDate): PT-2026-045,95.0,180.0,42.0,7400,Lu177,3,14800,2026-02-20T09:00:00Z — WHY IS THIS NEEDED? Prescribing radiopharmaceutical therapy (Lu-177-PSMA, Lu-177-DOTATATE, Ac-225) requires precise activity calculation: • Dose per kg body weight — baseline efficacy parameter • Renal function (GFR) — key safety factor (isotopes excreted by kidneys) • Cumulative dose — limit for entire treatment course (bone marrow/kidney protection) • Cycle interval — recovery time (min 6–8 weeks) ⚠️ CRITICAL: • GFR < 60 ml/min — dose reduction by 25–50% required • GFR < 15 ml/min — therapy contraindicated! • Exceeding cumulative dose (>45 GBq for Lu-177) — risk of irreversible myelosuppression • Interval < 6 weeks — high toxicity risk Critical parameters: • Dose per kg: 7.4 MBq/kg ±10% (for Lu-177) • GFR: ≥60 ml/min (full dose), 30–59 (reduction), <15 (prohibited) • Cumulative dose: ≤45 GBq (Lu-177), ≤15 MBq (Ac-225) • Cycle interval: ≥42 days ⚠️ Note: Utility automatically calculates correction factor for renal impairment and compares cumulative dose against toxicity limits. Result includes status (APPROVED/WARNING/REJECTED) and specific recommendation.
input.csv
PatientID,WeightKg,HeightCm,GFR_MLMin,PrescribedActivityMBq,Radionuclide,CycleNumber,PreviousDoseMBq,LastTreatmentDate PT-2026-045,95.0,180.0,42.0,7400,Lu177,3,14800,2026-02-20T09:00:00Z PT-2026-046,80.0,175.0,85.0,7400,Lu177,1,0,2025-12-01T10:00:00Z
URS & FS — user requirements and functional specification
This document defines user requirements and functional specification for the quality-control utility. It supports deployment discussion, IQ/OQ preparation and QC workflow integration.
1. Scope
The Activity Prescription Checker utility is used for Activity Prescription. The actual input.csv is the source of truth for the input structure; control criteria are defined by the executable and the domain description.
The utility does not use machine learning; decisions are produced by deterministic rules.
Categories: Radiation physics
Tags: activity, brachytherapy, dosimetry, radiopharma, source calibration, TG-43
2. Execution modes
ActivityPrescriptionChecker.exe → demo mode (console output) ActivityPrescriptionChecker.exe input.csv output.json → evaluate your data
3. Key controlled areas
- pH and physicochemical parameters
- activity, decay and radiochemical purity
4. Domain limits and critical parameters
- ⚠️ Critical for theranostics! Dose calculation errors lead to nephrotoxicity or treatment inefficacy. Strict renal function control is mandatory!
- ⚠️ CRITICAL:
- GFR < 60 ml/min — dose reduction by 25–50% required
- GFR < 15 ml/min — therapy contraindicated!
- Exceeding cumulative dose (>45 GBq for Lu-177) — risk of irreversible myelosuppression
- Interval < 6 weeks — high toxicity risk
- Critical parameters:
- Dose per kg: 7.4 MBq/kg ±10% (for Lu-177)
- GFR: ≥60 ml/min (full dose), 30–59 (reduction), <15 (prohibited)
- Cumulative dose: ≤45 GBq (Lu-177), ≤15 MBq (Ac-225)
- Cycle interval: ≥42 days
- ⚠️ Note: Utility automatically calculates correction factor for renal impairment and compares cumulative dose against toxicity limits. Result includes status (APPROVED/WARNING/REJECTED) and specific recommendation.
5. URS — user requirements
| ID | Requirement | Criticality | Acceptance criterion |
|---|---|---|---|
| URS-001 | The system shall accept an input.csv file for Activity Prescription with the exact columns listed in the “Input data contract” section. | High | A file with the correct header is processed without manual editing; missing mandatory columns produce FAIL/import error. |
| URS-002 | The system shall support execution without arguments in demo mode and execution with input.csv output.json for user data. | Medium | Both execution scenarios produce a predictable result or clear diagnostic error. |
| URS-003 | The system shall perform rule-based controls for: pH and physicochemical parameters, activity, decay and radiochemical purity. | High | Each controlled parameter receives a status and message; the result does not depend on hidden Excel formulas or ML. |
| URS-004 | The system shall preserve traceability between batch/lot, source values, applied rules and final verdict. | High | Output includes batch identifier, source values, parameter statuses and critical findings. |
| URS-005 | The system shall generate machine-readable output.json for LIMS/ELN/MES, batch record and QA/QC review. | High | JSON contains overall status, check array, warnings, failures and source-file reference. |
| URS-006 | The system shall support use in the client validation package: URS/FS, IQ/OQ preparation, installation and operational scenario checks. | High | The document, test scenarios and reproducible CSV/JSON flow are suitable for audit and internal approval. |
| URS-007 | The system shall clearly separate technical data errors from specification nonconformities. | Medium | Schema/type errors are not mixed with pharmacopoeial deviations and are reported separately. |
6. input.csv data contract
The source of truth for the input schema is the actual input.csv header. Column names are technical identifiers and are not translated.
| # | Column | Type | Unit | Description | Sample | Control rule |
|---|---|---|---|---|---|---|
| 1 | PatientID | text | as specified | Patient ID | PT-2026-045 | mandatory value; format and acceptability are checked by the utility |
| 2 | WeightKg | decimal | as specified | Weight Kg | 95.0 | mandatory numeric value; rule comparison is performed by the utility |
| 3 | HeightCm | decimal | as specified | Height Cm | 180.0 | mandatory numeric value; rule comparison is performed by the utility |
| 4 | GFR_MLMin | decimal | min | GFR MLMin | 42.0 | mandatory numeric value; rule comparison is performed by the utility |
| 5 | PrescribedActivityMBq | decimal | MBq | Prescribed Activity MBq | 7400 | mandatory numeric value; rule comparison is performed by the utility |
| 6 | Radionuclide | text | as specified | Radionuclide | Lu177 | mandatory value; format and acceptability are checked by the utility |
| 7 | CycleNumber | decimal | as specified | Cycle Number | 3 | mandatory numeric value; rule comparison is performed by the utility |
| 8 | PreviousDoseMBq | decimal | MBq | Previous Dose MBq | 14800 | mandatory numeric value; rule comparison is performed by the utility |
| 9 | LastTreatmentDate | date/time | as specified | Last Treatment Date | 2026-02-20T09:00:00Z | mandatory value; format and acceptability are checked by the utility |
CSV example
PatientID,WeightKg,HeightCm,GFR_MLMin,PrescribedActivityMBq,Radionuclide,CycleNumber,PreviousDoseMBq,LastTreatmentDate PT-2026-045,95.0,180.0,42.0,7400,Lu177,3,14800,2026-02-20T09:00:00Z
7. FS — functional specification
| ID | Function | Implementation description |
|---|---|---|
| FS-001 | CLI entry point | The executable ActivityPrescriptionChecker.exe supports demo mode and input.csv output.json processing mode. |
| FS-002 | CSV parser | The import module reads CSV, validates header, column presence/order, value count and encoding. Decimal values are expected with a dot separator. |
| FS-003 | Field conversion | Each column is converted to the expected type: identifier, text, decimal number, date/time or boolean flag. |
| FS-004 | Domain rule engine | For Activity Prescription, explicit rules are applied: range, minimum, maximum, absence of prohibited flag, data completeness or calculation-based check. |
| FS-005 | Criticality handling | Critical violations produce FAIL; non-critical deviations and incomplete data produce WARNING; full conformance produces PASS. |
| FS-006 | JSON writer | output.json stores overall status, per-parameter results, source values, warnings, failures and diagnostic messages. |
| FS-007 | Integration contract | The CSV → JSON format is stable for invocation from LIMS/ELN/MES, scheduled task or wrapper service. |
| FS-008 | Error handling | Schema error, missing file, non-numeric value or JSON write failure returns diagnosable error without silent PASS. |
8. output.json contract
The output file must be suitable for automated processing, audit review and correlation with the source input.csv row.
{
"utility": "ActivityPrescriptionChecker",
"api": "Activity Prescription",
"batchNumber": "",
"overallStatus": "PASS|WARNING|FAIL",
"checkedAtUtc": "2026-05-18T00:00:00Z",
"checks": [
{
"parameter": "PatientID",
"value": "PT-2026-045",
"unit": "as specified",
"status": "PASS|WARNING|FAIL",
"message": "Rule-based check result"
},
{
"parameter": "WeightKg",
"value": "95.0",
"unit": "as specified",
"status": "PASS|WARNING|FAIL",
"message": "Rule-based check result"
},
{
"parameter": "HeightCm",
"value": "180.0",
"unit": "as specified",
"status": "PASS|WARNING|FAIL",
"message": "Rule-based check result"
},
{
"parameter": "GFR_MLMin",
"value": "42.0",
"unit": "min",
"status": "PASS|WARNING|FAIL",
"message": "Rule-based check result"
},
{
"parameter": "PrescribedActivityMBq",
"value": "7400",
"unit": "MBq",
"status": "PASS|WARNING|FAIL",
"message": "Rule-based check result"
},
{
"parameter": "Radionuclide",
"value": "Lu177",
"unit": "as specified",
"status": "PASS|WARNING|FAIL",
"message": "Rule-based check result"
},
{
"parameter": "CycleNumber",
"value": "3",
"unit": "as specified",
"status": "PASS|WARNING|FAIL",
"message": "Rule-based check result"
},
{
"parameter": "PreviousDoseMBq",
"value": "14800",
"unit": "MBq",
"status": "PASS|WARNING|FAIL",
"message": "Rule-based check result"
}
],
"criticalFindings": [],
"sourceFile": "input.csv"
}9. OQ/PQ test scenarios
| ID | Scenario | Expected result |
|---|---|---|
| TC-001 | Valid CSV with expected header and sample row | All rows are processed; output contains PASS/WARNING/FAIL and parameter-level detail. |
| TC-002 | A mandatory input.csv column is missing | Import is rejected or the row receives FAIL with schema reference. |
| TC-003 | A numeric field contains text or a blank value | Type conversion error is recorded; the result is not hidden as PASS. |
| TC-004 | A parameter is outside specification or critical limit | Critical parameters produce FAIL; non-critical deviations produce WARNING according to the rule. |
| TC-008 | Incorrect activity, reference time or radiochemical purity | FAIL/WARNING is produced with calculation traceability. |
10. QA/QC, CSV and change control
- Before production use, the client records executable version, checksum, specification/monograph version, test CSV, expected JSON and IQ/OQ results.
- Column names must not be changed without updating the validator and test scenarios.
- The source CSV, output.json and utility version should be stored together as an evidence package.
- Any change in control rules must go through change control and repeated OQ scenario verification.
Included in packages
Radiation Physics QC Suite
Utilities for activity, dosimetry, brachytherapy sources, small-field corrections and TG-43 parameters.
OpenRadiology QC Suite
QC package for radiology and diagnostic imaging: radiopharmaceuticals, PET/SPECT, contrast media, iodinated and gadolinium products, plus particle, sterility and endotoxin checks.
OpenRPH isotope family: alpha-emitting therapy
Ac-225, Ra-223, At-211, Bi-213 and Th-227: targeted alpha therapy and daughter/recoil control.
OpenRPH isotope family: beta-emitting therapy
Lu-177, Y-90, Ho-166, Re-188, Sm-153, Sr-89, P-32, Cu-67 and Tb-161.
OpenRPH organ/system: bone and musculoskeletal
Bone scintigraphy, MDP/PYP, marrow, bone-pain palliation, skeletal metastases and radiosynovectomy.
OpenRPH organ/system: endocrine, thyroid and NET
Radioiodine, thyroid/parathyroid, somatostatin receptor, MIBG and neuroendocrine workflows.
OpenRPH organ/system: oncology and theranostics
Tumour imaging, PSMA/FAPI/receptor tracers, immuno-PET, targeted radionuclide therapy and radioembolization.
OpenRPH organ/system: renal and urinary
Renography, GFR/ERPF, renal uptake, DMSA/MAG3/DTPA and bladder-related workflows.
OpenRPH use case: PET scanner state, gamma camera and radiation physics
The linked medical-device/radiation-physics layer: PET detector QC, normalization, AC map, cross-calibration, TOF, gamma-camera uniformity, source strength and staff dose.
OpenRPH workflow: dosimetry and therapy planning
Activity planning, absorbed dose, organ dose, lung shunt, preplanning and therapy verification.
OpenRPH workflow: instruments, devices and radiation safety
PET/gamma-camera state, calibration, detector QC, energy window, TOF, shielding and radiation safety.
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