The number of donors in each simulation.

The number of replicates from each donor for each simulated dataset.

The estimated standard deviation of the reference measurements. The reference-scaled average bioequivalence approach is used if S_WR > 0.249 and the average bioequivalence approach otherwise.

(Optional) The list of true parameters to be assumed in data generation.

• sigma_W0 - A regulatory constant set by the FDA. Defaults to 0.25.

• GMR - The geometric mean ratio of the test and reference values of the pharmacokinetic measures (e.g., Jmax or AUC). If the test-formulation measure is greater than that of the reference formulation, then GMR is typically set to 1.05, which is the initial value of this function. If the reference-formulation measure is bigger, then GMR is typically 0.95. Defaults to 0.95.

• m - Another regulatory constant that determines the bounds within which the estimated GMR should fall for bioequivalence to be established. Defaults to 1.25, representing 80-125% average BE limits, which is the FDA recommendation.

• sig_level - The significance level (alpha-level).

• nmax - The upper limit for sample size reestimation. If the sample size exceeds nmax inside estimation procedure, the function will return nmax.

• target_power - The threshold for power (or passing rate) for a hypothesis test to be considered powerful. Typically set at 80% and defaults to 0.8.

(Optional) The number of total simulations to be conducted. Defaults to 1,000.

(Optional) The number of CPU cores to use for parallel processing (OpenMP). If R hasn't been installed with OpenMP configured, this will not take effect. When OpenMP is available, it should not exceed the number of existing cores. If unspecified, it will default to 2 cores or the number of existing cores, whichever is smaller.