NCA, Bioequivalence, Food-Effect and Dose-Proportionality
reports — the standard regulatory PK analyses, generated
automatically from a CSV. Plus three advanced engines
(Population PK, Tumor Growth, Drug Release) for cases where
classical exponential models miss the picture. Non-regulated
reports, automatic verdict, PDF in your inbox.
Public beta — free. NCA, Tumor Growth and Drug Release
are open now: upload your CSV directly, no signup. Reports are
indicative (not for regulatory submission) and your data is deleted
within 1 hour. Population PK is available on request. The NCA engine is
validated against PKNCA 0.12.1 on the public reference theophylline
dataset — see
Algorithm Validation.
The seven sample reports below use synthetic demonstration datasets,
labelled as such in every PDF.
Live sample · NCA report
FractaLPK Engine
Observed concentration
Population mean ± SD
Time →
Concentration ↑
NCA — Population summary
Cmax, AUC0-t, AUC0-∞, λz, t½
Validated
PKNCA-alignedQuality flags per subjectRegulatory disclaimer
Validated against PKNCA 0.12.1 on the reference theophylline
dataset — agreement within 0.15 % on AUC-class parameters,
bit-identical Cmax/Tmax.
From the NCA showcase (24 synthetic subjects, declared units). The selling
point isn't the plot — it's that the report refuses to report a λz it
cannot defend, names the excluded subject, and gives the reason.
Subjects without a reportable λz — full traceability
This is what Phoenix does not do out of the box: when the terminal slope
fails the reportability criteria (adjusted R² ≥ 0.90 over ≥ 3 points),
the λz-derived parameters come back N/A with a named reason — not a
confident-looking number the data don't support.
Concentration–time (semi-log), individual profiles + population mean.
Per-subject λz regression diagnostics — the points used, the fit, the R².
How it works
Open engines upload directly during the beta; request access for Population PK or proprietary-compound work.
Step 1
Explore the samples
Seven engines, seven synthetic demonstration datasets (labelled as such in every PDF). Open each one to see the verdict, models compared and diagnostic plots — exactly the report a paying client receives.
Step 2
Request access
The open engines (NCA, Tumor, Drug Release) need no request — upload directly during the beta. For Population PK or proprietary-compound work, tell us your name, company and what you're analysing; we reply within one business day with an upload link.
Step 3
Upload & receive
Upload your CSV, get a magic-link to the PDF when the fit completes (typically 5–10 minutes), and a copy in your inbox. No subscription, no commitment.
Live samples — open the PDFs
Each PDF is generated by the same engine that processes your uploads —
same plots, same verdict logic, same honest exclusions and named
non-reportable subjects.
The first four are the standard regulatory PK reports.
The last three are the advanced fractional engines — see
Advanced engines below.
Algorithm Validation
The NCA engine is cross-validated against PKNCA, the de-facto open-source standard for non-compartmental analysis.
NCA engine validated against PKNCA 0.12.1 on the public reference theophylline dataset (12 subjects, single oral dose). Agreement is within
0.15 % on AUC-class parameters and
bit-identical on Cmax and Tmax across every subject.
Pinned versions, full method-alignment table and per-subject diff are in the report.
Scope: this validation covers the NCA engine specifically. Bioequivalence wraps the same NCA core. Food-Effect and Dose-Proportionality are exploratory — not yet validated against reference software. The advanced fractional engines (PopPK, Tumor, Drug Release) are non-regulated screening tools and are not subject to this cross-validation.
Built for early-stage screening, when you need a fast answer before opening a full regulatory analysis.
Fractional models
Detect memory effects and long tails that classical exponential models flatten out — common in fractured tablets, heterogeneous tissue and saturating tumour growth.
Multi-model verdict
Up to 8 candidate models fitted in parallel. The engine ranks them and applies an explicit decision rule — no manual model-selection bias.
Automatic diagnostics
Stability check, residuals and "Best fit" badge in every report. If no model wins clearly, the PDF says so — no false-positive verdicts.
Built for screening
Non-regulated, designed to sit before NONMEM / Monolix / PKanalix. Good for biotech early-stage, CROs running internal triage, and academic exploration.
Why not just use R + PsN?
R + PsN gives you the numbers. It does not give you a deliverable that
declares its own limits, marks its own non-reportable subjects, and
refuses to compute what it cannot defend. That deliverable is the product.
Marks its own non-reportable subjects
When a subject's terminal slope fails the reportability criteria, its λz-derived parameters come back N/A — listed by name, with the reason, in a "Subjects without a reportable λz" section. bbr / pmtables give you tables; they don't decide what should not be reported.
Refuses to compute what it can't defend
No CL/F when you haven't declared the dose units. No [P5, P95] at n < 5. No CTD node it cannot assign. Numbers appear at the precision the data support, and not otherwise — epistemic honesty is the point, not a footnote.
Zero R, zero NONMEM
Upload a CSV, receive a regulatory-format PDF + editable Word skeleton. The R stack assumes you already have a run and know how to write Quarto templates, pmtables headers and Xpose plotting code.
Minutes, not days of setup
CSV upload to PDF in your inbox: 5–10 min. Standing up an R / Quarto / PsN pipeline that produces the same self-documenting artefact takes a senior pharmacometrician days to weeks.
When FractaLPK is NOT for you: if you have an in-house pharmacometrics team already running PsN / bbr / pmtables, FractaLPK does not replace that workflow — your team's R pipeline is the right tool. FractaLPK is built for biotechs, CROs and academic groups that need a fast PK answer before opening a full regulatory analysis.
The standard NCA / BE / FE / DP reports cover the regulatory baseline. The three advanced engines below are for cases where classical exponential ODEs visibly miss the data.
Population PK
Multi-compartment + fractional / Mittag-Leffler PK fits with explicit model-selection rule. For profiles where the terminal phase is heavier than a sum of exponentials predicts.
These three engines are research / screening tools; they are NOT cross-validated against PKNCA or any other regulatory reference. The "Best fit" verdict and fractional-model selection are FractaLPK's own decision rules, designed for early triage, not regulatory submission.
Pricing
An outsourced NCA analysis at a CRO runs into thousands of euros per study;
a pharmacometrics software licence, thousands per year. FractaLPK is
compliance infrastructure — a report you can defend — not a per-unit PDF.
Free during the public beta · pricing at launch.
Public beta
Free · no signup
Open right now
Upload your own CSV to NCA, Tumor Growth and Drug Release — free, no account.
Automatic verdict + full PDF in your inbox.
Indicative reports; your data deleted within 1 hour.