SimTOST: Sample Size Estimation via Simulation

In SimTOST: Sample Size Estimation for Bio-Equivalence Trials Through Simulation

Sample Size Estimation via Simulation

Description

SimTOST: A Package for Sample Size Simulations

Details

The SimTOST package provides tools for simulating sample sizes, calculating power, and assessing type-I error for various statistical scenarios.

Planning

Each function name links to its full help page.

• sampleSize: simulation-based sample-size planning for continuous and count outcomes, including multiple endpoints and comparator families.

• simPower: simulated power for a fixed sample size, with support for continuous and count-outcome analyses.

• sampleSize_Mielke: Mielke et al.'s sample-size calculation for multiple, correlated hypotheses and k-out-of-m rules.

Continuous outcomes

• simParallelEndpoints: generates correlated normal or log-normal endpoint data for a parallel-group design.

• get_par: prepares and validates endpoint, covariance, allocation, and hierarchy parameters for planning.

• run_simulations: dispatches a continuous simulation to the selected design and test combination.

Simulation-result methods

• print.simss (print): prints a concise design, power, confidence-interval, and sample-size report.

• summary.simss (summary): returns and prints a structured summary of the simulation result.

• confint.simss (confint): extracts the stored Monte Carlo confidence interval for achieved power.

• plot.simss (plot): plots simulated power against sample size with confidence intervals and the target-power line.

• update.simss and update.simpower (update): reruns a result while replacing only explicitly supplied planning or simulation parameters.

Author(s)

Thomas Debray [e-mail] (author and maintainer)

Other contributors:

• Tim Friede [e-mail] [contributor]

• Johanna Munoz [e-mail] [contributor]

• Dewi Amaliah [e-mail] [contributor]

• Wei Wei [e-mail] [contributor]

• Marian Mitroiu [e-mail] [contributor]

• Scott McDonald [e-mail] [contributor]

• Biogen Inc [copyright holder, funder] (original implementation v1.0.0)

• Smart Data Analysis and Statistics B.V. [copyright holder, funder] (subsequent developments)

References

Mielke, J., Jones, B., Jilma, B. & König, F. Sample Size for Multiple Hypothesis Testing in Biosimilar Development. Statistics in Biopharmaceutical Research 10, 39–49 (2018).

See Also

Useful links:

• https://smartdata-analysis-and-statistics.github.io/SimTOST/

SimTOST documentation built on Oct. 9, 2026, 5:07 p.m.