Approved route → target route → matched exposure → human decision

Bridge routes without pretending the routes are equivalent.

Characterize an approved reference regimen, model the target-route absorption and bioavailability, explore dose × interval × strength scenarios, compare AUC/Cmax/Cmin/Tmax, apply PK/PD and formulation constraints, propagate uncertainty, then preserve the result as COMPUTED evidence for accountable review.

Reference PKSC depot modelExposure matchingPK/PDFormulation feasibilityVirtual populationHuman review

Analysis plan

Inputs remain explicit. No silent assumption becomes a measurement.

1Reference product

Reference route

Dose (mg)

Interval (h)

Bioavailability F

Clearance (L/h)

Central V (L)

Q (L/h)

Peripheral V (L)

Ka (1/h)

Duration (h)

2Target route

Target route

Absorption model

Target F

Target Ka (1/h)

Lag (h)

Solubility (mg/mL)

Candidate doses (mg)

Intervals (h)

Strengths (mg/mL)

Max injection volume (mL)

3Prespecified matching criteria

AUC ratio min

AUC ratio max

Cmax ratio min

Cmax ratio max

Cmin ratio min (optional)

Cmin ratio max

4Uncertainty

Virtual subjects

Seed

CL CV

Ka CV

This workspace is decision support. Matching corridors shown in the example are not universal clinical acceptance criteria; replace them with analysis-plan criteria for the asset.

Route bridge result

Reference versus candidate target-route exposure, with explicit fail-closed qualification.

Run a route bridge to populate exposure matching, qualified regimens and uncertainty.

Reference AUCτ—

Reference Cmax—

Qualified regimens—

Decision state—

Dose	Interval	Strength	Volume	AUC ratio	Cmax ratio	Cmin ratio	PK	Formulation	Status

Virtual population

Runs only for the best qualified regimen.

Evidence boundary

Report package / audit payload

BayesPharma · Route Extrapolation Studio · COMPUTED ≠ MEASURED · No automatic dose authorization · Human MIDD review required.