Fractional-order pharmacokinetic modeling, classical PK analysis, and regulatory support. We detect and quantify anomalous diffusion where classical models fall short.
Scientific collaboration with F.A.T. Laboratories, University of Athens. Scientific Director: Prof. Panos Macheras, FAAPS, FAIBME.
Capabilities unique to FractaLPK — not available in NONMEM, Monolix or Phoenix WinNonlin.
Upload your dataset and receive a one-page screening report within 24 hours: is anomalous diffusion present? Includes ΔOFV, p-value, and percentage of subjects affected. The fastest way to know if fractional PK applies to your compound. No commitment required for full analysis.
24H TURNAROUNDOral, IV, SC, IM routes with fractional absorption and/or elimination. Individual and population level.
UNIQUETwo-compartment fractional kinetics. Captures anomalous tissue distribution classical models miss.
UNIQUEThree-compartment fractional modeling for complex distribution — CNS drugs, highly lipophilic compounds, tumor penetration. Not available in NONMEM or Phoenix.
UNIQUECombined oral + transdermal or oral + SC modeling. Validated on Donepezil BE (N=44, H=0.950 vs NONMEM 0.894).
VALIDATEDPooled population estimation of fractional exponent H. Quantifies what percentage of subjects show anomalous diffusion. Not available in any other platform.
UNIQUEIndividual H estimation reveals PK subgroups masked by classical models. Validated: Abacavir N=169 children, 40.2% anomalous (H range 0.518–2.348).
VALIDATEDYour existing NONMEM results + FractaLPK analysis in a single comparative document ready for submission.
UNIQUEFull set of classical pharmacokinetic services, NONMEM-comparable methodology.
Automatic AUC, Cmax, Tmax, t½, CL/F, Vd/F calculation. Anomaly flagging for subjects with terminal slope α < 0.95.
STANDARD1-CMT, 2-CMT, 3-CMT individual and population fitting. Oral, IV, SC, IM routes. Goodness-of-fit plots and weighted residuals.
STANDARDPooled nonlinear mixed-effects analysis. Covariate screening (weight, age, renal function, genotype). NONMEM-comparable OFV.
STANDARDStandard BE metrics (AUC ratio, Cmax ratio, TOST 90% CI). Individual α estimation identifies BE failures driven by anomalous absorption vs formulation differences.
STANDARDQuantitative DDI analysis with victim/perpetrator modeling. Mechanistic static and dynamic models available.
STANDARDRenal/hepatic impairment, elderly, pediatric. Covariate models with clinical interpretation for dose adjustment recommendations.
STANDARDSubmission-ready deliverables and strategic modeling support.
FractaLPK analysis reports formatted for inclusion in IND/NDA pharmacokinetic sections. Includes plain-language rationale for fractional model selection, suitable for regulatory reviewer review.
REGULATORYMIDD strategy: PK/PD integration, exposure-response modeling, dose justification. Support for advisory meetings with regulatory agencies.
REGULATORYSimulated dosing regimens for special populations. Optimal dose recommendations based on exposure targets and safety margins.
REGULATORYFull PopPK reports ready for submission. Executive summary, methods, results, discussion, and appendix following industry standards.
REGULATORYContact: cperapa@fractalpk.es
Subject: [Service name] — [Compound name]
Include a brief description of your dataset (N subjects, route of administration, sampling design), your analysis objective, and timeline. We respond within 2 business days with a preliminary assessment.
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