RadiationDoseCalculator

Radiation Dose Calculator

decay correction endotoxins PET radionuclide purity radiopharma SPECT sterility

Radiation Dose Calculator — Patient absorbed dose calculator

ℹ️ Utility calculates ESTIMATED absorbed dose based on ICRP data (ICRP 106, 128):
• Effective dose (mSv) for overall radiation burden assessment
• Target organ and critical organ doses (mGy)
• Patient weight correction
• Dose limit compliance check

⚠️ IMPORTANT: Result is PRELIMINARY ESTIMATE and does NOT replace official
MIRD dosimetry. Used for safety decision-making before radiopharmaceutical
administration in clinical practice.

Usage:
RadiationDoseCalculator.exe → demo mode (console output)
RadiationDoseCalculator.exe input.csv output.json → calculate with your data

Input format:
PatientID,Nuclide,AdministeredActivityMBq,PatientWeightKg,TargetOrgan,PatientSex

Examples:
PT-RA223-001,Ra-223,1100.0,100.0,BoneSurface,M ← bone metastasis therapy
PT-LU177-001,Lu-177,6000.0,75.0,Kidneys,M ← PSMA-positive prostate cancer therapy
PT-F18-001,F-18,370.0,70.0,BladderWall,F ← diagnostic FDG PET

— WHY IS THIS NEEDED?
Absorbed dose assessment is critical before radiopharmaceutical administration:
• For THERAPEUTIC agents (radium-223, lutetium-177) — prevention of critical organ toxicity
(kidneys, bone marrow, bone surface)
• For DIAGNOSTIC agents (fluorine-18, technetium-99m) — minimization of radiation burden
while maintaining image quality
• For regulatory compliance (dose limits per ICRP, national regulations)

⚠️ CRITICAL:
• Utility uses SIMPLIFIED dosimetry model based on public ICRP data
• For precise personalized dosimetry, MIRD method required with:
— Patient-specific radiopharmaceutical biokinetics
— CT/PET imaging for organ mass determination
— Individual pharmacokinetic parameters
• Dose limits for therapy:
— Red bone marrow: ≤2 Gy per course
— Kidneys (for 177Lu): ≤23 Gy per course
— Bone surface: ≤50 Gy per course
• Effective dose for diagnostics:
— FDG (fluorine-18): ~7 mSv at 370 MBq
— Gallium-68 DOTATATE: ~4.4 mSv at 150 MBq

Key features:
• Support for 8 key radionuclides with ICRP data
• Automatic patient weight correction (relative to 70 kg)
• Dose calculation for target organ and all critical organs
• Dose limit compliance check with safety margin (%)
• Patient sex support (for future sex-specific extensions)
• Demo mode with clinically relevant examples

Supported radionuclides and critical organs:
• Radium-223: bone surface (1.8 mGy/MBq), red marrow (0.45 mGy/MBq)
• Lutetium-177: kidneys (0.49 mGy/MBq), red marrow (0.31 mGy/MBq)
• Iodine-131: thyroid (0.23 mGy/MBq), red marrow (0.10 mGy/MBq)
• Strontium-89: bone surface (2.1 mGy/MBq), red marrow (0.55 mGy/MBq)
• Fluorine-18: bladder wall (0.044 mGy/MBq), red marrow (0.018 mGy/MBq)
• Gallium-68: kidneys (0.055 mGy/MBq), adrenals (0.032 mGy/MBq)
• Technetium-99m: bladder wall (0.015 mGy/MBq)
• Indium-111: kidneys (0.12 mGy/MBq), liver (0.08 mGy/MBq)

💡 Usage tips:
1. For therapeutic agents ALWAYS check critical organ doses
2. If limit exceeded (>100%), consider:
• Reduced administered activity
• Increased interval between administrations
• Alternative agent/therapy method
3. For diagnostics compare effective dose with natural background (~2.4 mSv/year)
4. Account for cumulative dose in repeated studies/therapies

⚠️ Limitations:
• Does not account for individual radiopharmaceutical biokinetics
• Does not account for pathological organ changes (metastases, cirrhosis)
• Does not replace official dosimetry for clinical trials
• Data based on ICRP population average values

Data sources:
• ICRP Publication 106 (2008) — Radiopharmaceuticals
• ICRP Publication 128 (2015) — ICRP Statement on Tissue Reactions
• EANM Dosimetry Committee guidelines
• FDA guidance on radiation dosimetry for radiopharmaceuticals

input.csv

PatientID,Nuclide,AdministeredActivityMBq,PatientWeightKg,TargetOrgan,PatientSex
PT-RA223-001,Ra-223,1100.0,100.0,BoneSurface,M
PT-LU177-001,Lu-177,6000.0,75.0,Kidneys,M
PT-F18-001,F-18,370.0,70.0,BladderWall,F
PT-I131-001,I-131,5550.0,80.0,Thyroid,M
PT-SR89-001,Sr-89,148.0,70.0,BoneSurface,F

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.

Utility: RadiationDoseCalculatorAPI / object: Radiation Dose CalculatorCategory: Radiopharmaceuticals

1. Scope

The Radiation Dose Calculator utility is used for Radiation Dose Calculator. 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: Radiopharmaceuticals

Tags: decay correction, endotoxins, PET, radionuclide purity, radiopharma, SPECT, sterility

2. Execution modes

RadiationDoseCalculator.exe                            → demo mode (console output)
RadiationDoseCalculator.exe input.csv output.json      → calculate with your data

3. Key controlled areas

purity and impurities
microbiology and pathogens
pH and physicochemical parameters
activity, decay and radiochemical purity

4. Domain limits and critical parameters

⚠️ IMPORTANT: Result is PRELIMINARY ESTIMATE and does NOT replace official
⚠️ CRITICAL:
Utility uses SIMPLIFIED dosimetry model based on public ICRP data
For precise personalized dosimetry, MIRD method required with:
Dose limits for therapy:
— Red bone marrow: ≤2 Gy per course
— Kidneys (for 177Lu): ≤23 Gy per course
— Bone surface: ≤50 Gy per course
Effective dose for diagnostics:
— FDG (fluorine-18): ~7 mSv at 370 MBq
— Gallium-68 DOTATATE: ~4.4 mSv at 150 MBq
Support for 8 key radionuclides with ICRP data
Automatic patient weight correction (relative to 70 kg)
Dose calculation for target organ and all critical organs
Dose limit compliance check with safety margin (%)
Patient sex support (for future sex-specific extensions)
Demo mode with clinically relevant examples
Radium-223: bone surface (1.8 mGy/MBq), red marrow (0.45 mGy/MBq)
Lutetium-177: kidneys (0.49 mGy/MBq), red marrow (0.31 mGy/MBq)
Iodine-131: thyroid (0.23 mGy/MBq), red marrow (0.10 mGy/MBq)
Strontium-89: bone surface (2.1 mGy/MBq), red marrow (0.55 mGy/MBq)
Fluorine-18: bladder wall (0.044 mGy/MBq), red marrow (0.018 mGy/MBq)
Gallium-68: kidneys (0.055 mGy/MBq), adrenals (0.032 mGy/MBq)
Technetium-99m: bladder wall (0.015 mGy/MBq)

Limits stated in the description must be verified against the current approved specification, pharmacopoeial monograph and registration dossier before production use.

5. URS — user requirements

ID	Requirement	Criticality	Acceptance criterion
URS-001	The system shall accept an `input.csv` file for Radiation Dose Calculator 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: purity and impurities, microbiology and pathogens, 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-RA223-001`	mandatory value; format and acceptability are checked by the utility
2	`Nuclide`	text	as specified	Nuclide	`Ra-223`	mandatory value; format and acceptability are checked by the utility
3	`AdministeredActivityMBq`	decimal	MBq	Administered Activity MBq	`1100.0`	mandatory numeric value; rule comparison is performed by the utility
4	`PatientWeightKg`	decimal	as specified	Patient Weight Kg	`100.0`	mandatory numeric value; rule comparison is performed by the utility
5	`TargetOrgan`	text	as specified	Target Organ	`BoneSurface`	mandatory value; format and acceptability are checked by the utility
6	`PatientSex`	text	as specified	Patient Sex	`M`	mandatory value; format and acceptability are checked by the utility

CSV example

PatientID,Nuclide,AdministeredActivityMBq,PatientWeightKg,TargetOrgan,PatientSex
PT-RA223-001,Ra-223,1100.0,100.0,BoneSurface,M

7. FS — functional specification

ID	Function	Implementation description
FS-001	CLI entry point	The executable `RadiationDoseCalculator.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 Radiation Dose Calculator, 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": "RadiationDoseCalculator",
  "api": "Radiation Dose Calculator",
  "batchNumber": "",
  "overallStatus": "PASS|WARNING|FAIL",
  "checkedAtUtc": "2026-05-18T00:00:00Z",
  "checks": [
    {
      "parameter": "PatientID",
      "value": "PT-RA223-001",
      "unit": "as specified",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Nuclide",
      "value": "Ra-223",
      "unit": "as specified",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "AdministeredActivityMBq",
      "value": "1100.0",
      "unit": "MBq",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "PatientWeightKg",
      "value": "100.0",
      "unit": "as specified",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "TargetOrgan",
      "value": "BoneSurface",
      "unit": "as specified",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "PatientSex",
      "value": "M",
      "unit": "as specified",
      "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

Andrology QC Suite

QC package for andrology: androgens, erectile-dysfunction medicines, BPH/prostate products, fertility and related hormonal checks.

RadiationDoseCalculator

input.csv

1. Scope

2. Execution modes

3. Key controlled areas

4. Domain limits and critical parameters

5. URS — user requirements

6. input.csv data contract

CSV example

7. FS — functional specification

8. output.json contract

9. OQ/PQ test scenarios

10. QA/QC, CSV and change control

Included in packages

Andrology QC Suite

Endocrinology QC Suite

PetRad QC Suite

Radiology QC Suite

RPH organ/system: bone and musculoskeletal

RPH organ/system: endocrine, thyroid and NET

RPH organ/system: hepatobiliary and GI

RPH organ/system: oncology and theranostics

RPH organ/system: renal and urinary

RPH use case: generators, isotope purity and starting radionuclides

RPH workflow: dosimetry and therapy planning

RPH workflow: generators and isotope purity

RPH workflow: imaging QC and quantitative interpretation

RPH workflow: product release QC

RPH workflow: stability, storage, decay and waste

RPH: combined radiopharmaceutical QC package

Urology QC Suite