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instrument mechanism / verified-clean

Loading & Maintenance Dose Calculator mechanism

The inspectable method record for Loading & Maintenance Dose Calculator, kept separate from implementation and qualification.

Status: VERIFIED_CLEANLifecycle: verified-clean

Model scope

The formulas are valid simplified pharmacokinetic formulas under consistent units, first-order linear kinetics, and F = 1. The specification needs an explicit distinction between maintenance dose per interval and maintenance rate, plus an explicit bioavailability assumption and target-concentration definition. The existing educational-only, not-medical-advice label is appropriate but does not resolve these ambiguities.

  • MD = target concentration × clearance × dosing interval is the standard maintenance dose per dosing interval, not a maintenance rate; the maintenance rate would be target concentration × clearance. The output label 'maintenance dose/rate' is ambiguous.
  • Both formulas implicitly assume bioavailability F = 1. If oral, extravascular, or otherwise incomplete administration is supported, the standard formulas require division by F: LD = Cp,target × Vd / F and maintenance dose = Cp,target × CL × τ / F.
  • The loading-dose formula assumes the target concentration is the concentration to be achieved immediately and that the relevant volume of distribution is known; the target may need to be distinguished as target steady-state average, peak, or trough concentration.

Units and conventions

  • Target concentration must use concentration units compatible with clearance and volume of distribution; for example, mg/L with Vd in L and CL in L/h.
  • Vd must be in volume units and clearance in volume-per-time units.
  • Dosing interval τ must be in the same time unit used in clearance; with CL in L/h, τ must be in hours.
  • With mg/L, L, and hours, loading dose and maintenance dose are in mg, and maintenance rate is in mg/h.
  • The calculations assume F = 1, no dose rounding, and no unit conversion beyond explicitly supplied inputs.

Inspectable vector

One of 4 source-bound review vectors:

{
  "inputs": {
    "target_concentration": "10 mg/L",
    "Vd": "35 L",
    "clearance": "4.2 L/h",
    "dosing_interval": "12 h"
  },
  "expected_outputs": {
    "loading_dose": "350 mg",
    "maintenance_dose_per_interval": "504 mg",
    "maintenance_rate": "42 mg/h"
  },
  "working": "Loading dose = 10 mg/L × 35 L = 350 mg. Maintenance dose = 10 mg/L × 4.2 L/h × 12 h = 42 mg/h × 12 h = 504 mg. Maintenance rate = 10 mg/L × 4.2 L/h = 42 mg/h."
}

Failure boundary

BREAK_CLAIMED · SELF_FLAGGED

The extreme-magnitude vector produces Infinity for both outputs under plain JavaScript arithmetic. The instrument should reject non-finite inputs or outputs rather than display Infinity as a usable educational dose. The specification also contains no actual formula branch, so an implementation inventing a threshold-based branch would be unsupported.

Other records

Sources and evidence

These pointers bind the page to evidence. They do not grant authority or collapse verification into deployment.

  • VERIFIED_LEDGER.json
  • evidence-tranche4/tranche4-results.json
  • BOUNDARY_HAZARD_CATALOG.json