Reference-Scaled BE — ABEL / RSABE

Bioequivalence for highly-variable drugs from a replicate cross-over design. The within-subject variability of the reference (s_wR) scales the acceptance range: EMA ABEL widens the 80–125 % limits; FDA RSABE applies the linearised scaled criterion. ABEL is validated to machine precision against replicateBE::method.A.

1 · Paste your replicate-design data

Regulator Values already ln-transformed

One row per observation: subject, period, treatment (T/R), value (comma / tab / space separated; a header row is optional). The reference must be replicated (≥ 2 R per subject) in a replicate design (e.g. TRTR/RTRT, TRR/RTR/RRT).

2 · Result

Computational reference-scaled BE screening for highly-variable drugs. Not medical or regulatory advice; study design adequacy and the acceptance decision are the responsibility of the user's regulatory team.