Bioequivalence Study Report
Upload concentration-time data for two formulations (Test and Reference). The engine computes per-subject Cmax and AUC0-∞, derives the geometric mean ratio (T/R) and the 90 % confidence interval, and tests bioequivalence against the EMA / FDA 80.00 %–125.00 % acceptance window. You receive a clean PDF and a regulatory Word draft pre-structured for ICH M4 Module 5.3.1.2 (EMA Bioequivalence Guideline).
1 · Upload dataset
▶ 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,zeitDV— 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.