🧬 Bioequivalence
Bioequivalence 90% CI Assessment
Perform the standard Two One-Sided Tests (TOST) procedure. Calculate the Geometric Mean Ratio (GMR) and 90% Confidence Interval of Test vs. Reference formulations to evaluate bioequivalence relative to the standard 80.00%–125.00% limits.
Study Setup & Inputs
Enter comma or space separated raw values for Reference group.
Enter comma or space separated raw values for Test group. Note: for Crossover, data length must match Reference exactly (subject-paired).
Residual variability CV % on log scale.
Acceptance Standard:
To demonstrate bioequivalence, the 90% confidence interval of the Geometric Mean Ratio (T/R) must lie entirely within 80.00% to 125.00%.
To demonstrate bioequivalence, the 90% confidence interval of the Geometric Mean Ratio (T/R) must lie entirely within 80.00% to 125.00%.
Bioequivalence Verdict
Provide datasets or summaries and run the assessment to check bioequivalence.
Regulatory & Scientific Reference:
The log-transformation of pharmacokinetic variables (AUC and Cmax) is necessary because pharmacokinetic concentrations generally follow a log-normal distribution. The Two One-Sided Tests (TOST) procedure at the 5% significance level is equivalent to verifying whether the 90% confidence interval of the ratio of geometric means is within [80.00%, 125.00%] (FDA 21 CFR 320 / EMA Guideline on the Investigation of Bioequivalence).
The log-transformation of pharmacokinetic variables (AUC and Cmax) is necessary because pharmacokinetic concentrations generally follow a log-normal distribution. The Two One-Sided Tests (TOST) procedure at the 5% significance level is equivalent to verifying whether the 90% confidence interval of the ratio of geometric means is within [80.00%, 125.00%] (FDA 21 CFR 320 / EMA Guideline on the Investigation of Bioequivalence).