Food-Effect Bioavailability Report

Upload concentration-time data for two conditions (Fed and Fasted). The engine computes per-subject Cmax and AUC0-∞, derives the geometric mean ratio (Fed / Fasted) and the 90 % confidence interval, and tests against the FDA Food-Effect Guidance 2002 acceptance windows (AUC0-∞ 80–125 %, Cmax 70–143 %). You receive a clean PDF and a Word draft structured along ICH M4 Module 5.3.1.2 — exploratory, not yet validated against reference software.

Exploratory — under validation. This module is not yet validated against reference software and is not intended for regulatory submission. For 2×2 designs the headline statistic currently uses a paired-t (df = n−1), divergent from the validated ANOVA (df = n−2). Use for screening only.
Public beta — free while we gather feedback. Results are indicative, for research and internal QC, not a regulatory submission. Your dataset is processed in the EU and deleted within 1 hour.
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1 · Upload dataset

📂
Click or drag a CSV file
CSV: ID · TIME · DV · CONDITION (fed/fasted) [· PERIOD for crossover]
▶ Accepted CSV format · click to expand

Required columns (case-insensitive, NONMEM aliases accepted):

  • TIME — time since dose. Aliases: time, t, tad, time_h, time_hr, tiempo, temps, zeit
  • DV — observed concentration. Aliases: dv, conc, concentration, y, obs, value, concentracion, konzentration, valeur

Optional columns: ID (required for per-subject NCA), AMT (dose), EVID (event ID), MDV (missing DV flag), RATE, DVID, CMT.

Header flexibility — punctuation, case, and parenthesised units are tolerated. Time (h), TIME_H, time-h and timeh all map to TIME. ES/FR/DE headers (tiempo, temps, zeit, etc.) are also accepted.

Minimum size: 4 distinct time points.

Example:

ID,TIME,DV,AMT,EVID
1,0,0,320,1
1,0.5,4.2,0,0
1,1,6.0,0,0
1,2,5.5,0,0
1,4,3.8,0,0
1,8,2.0,0,0
1,12,1.1,0,0
1,24,0.4,0,0

Do NOT submit datasets with direct identifiers (names, dates of birth, contact details). Use pseudonymised IDs.

Starting…
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This report contains computational results. Pharmacological interpretation and clinical decisions are the responsibility of the client's expert team. FractaLPK does not provide medical, pharmacological, or regulatory advice.