# PowerTOST v1.4-7

0

0th

Percentile

## Power and Sample Size Based on Two One-Sided t-Tests (TOST) for (Bio)Equivalence Studies

Contains functions to calculate power and sample size for various study designs used for bioequivalence studies. See function known.designs() for study designs covered. Moreover the package contains functions for power and sample size based on 'expected' power in case of uncertain (estimated) variability and/or uncertain theta0. ----- Added are functions for the power and sample size for the ratio of two means with normally distributed data on the original scale (based on Fieller's confidence ('fiducial') interval). ----- Contains further functions for power and sample size calculations based on non-inferiority t-test. This is not a TOST procedure but eventually useful if the question of 'non-superiority' must be evaluated. The power and sample size calculations based on non-inferiority test may also performed via 'expected' power in case of uncertain (estimated) variability and/or uncertain theta0. ----- Contains functions power.scABEL() and sampleN.scABEL() to calculate power and sample size for the BE decision via scaled (widened) BE acceptance limits (EMA recommended) based on simulations. Contains also functions scABEL.ad() and sampleN.scABEL.ad() to iteratively adjust alpha in order to maintain the overall consumer risk in ABEL studies and adapt the sample size for the loss in power. Contains further functions power.RSABE() and sampleN.RSABE() to calculate power and sample size for the BE decision via reference scaled ABE criterion according to the FDA procedure based on simulations. Contains further functions power.NTIDFDA() and sampleN.NTIDFDA() to calculate power and sample size for the BE decision via the FDA procedure for NTID's based on simulations. Contains further functions power.HVNTID() and sampleN.HVNTID() to calculate power and sample size for the BE decision via the FDA procedure for highly variable NTID's (see FDA Dabigatran / rivaroxaban guidances) ----- Contains functions for power analysis of a sample size plan for ABE (pa.ABE()), scaled ABE (pa.scABE()) and scaled ABE for NTID's (pa.NTIDFDA()) analysing power if deviating from assumptions of the plan. ----- Contains further functions for power calculations / sample size estimation for dose proportionality studies using the Power model.

## Functions in PowerTOST

 Name Description power.HVNTID (Empirical) Power for BE decision via FDA method for highly variable NTIDs exppower.noninf Expected power of the non-inferiority test power.2TOST Power for two simultaneous TOST procedures power.RSABE2L.sdsims (Empirical) Power of BE Decision via Reference Scaled ABE power.RatioF Power for equivalence of the ratio of two means with normality on original scale expsampleN.TOST Sample size based on expected power bib.CL Design matrices of period balanced incomplete block designs power.scABEL (Empirical) Power of BE decision via scaled (widened) BE acceptance limits power.scABEL.sdsims (Empirical) Power of BE decision via scaled (widened) BE acceptance limits sampleN.scABEL.ad Sample size estimation for ABEL and iteratively adjusted alpha sampleN.scABEL Sample size estimation for BE decision via scaled (widened) BE acceptance limits known.designs Show the 'known' designs expsampleN.noninf Sample size based on expected power for the non-inferiority test pa.ABE Power analysis for average bioequivalence (ABE) ct9.6.4+ct9.6.8 Sample Size Tables for the 2x4x4 Replicate Crossover Design power.dp Power of dose-proportionality studies evaluated via Power model power.noninf Power of the one-sided non-inferiority t-test ctSJ.VIII.10+ctSJ.VIII.20+ctCW.III Sample Size Tables for the Parallel Group Design power.NTIDFDA (Empirical) Power for BE decision via FDA method for NTIDs scABEL Scaled (widened) BE Acceptance Limits scABEL.ad Iteratively adjusted alpha for ABEL type1error.2TOST Type I error rate for two simultaneous TOST procedures pvalue.TOST p-value(s) of the TOST procedure reg_const Constructor of an object with class 'regSet' containing the regulatory settings for ABEL power.RSABE (Empirical) Power for BE decision via linearized scaled ABE criterion sampleN.dp Sample size estimation of dose-proportionality studies evaluated via Power model sampleN.noninf Sample size for the non-inferiority t-test pa.NTIDFDA Power analysis for scaled ABE for NTIDs according to FDA pa.scABE Power analysis for scaled average bioequivalence (scABE) power.TOST Power of the classical TOST procedure power.TOST.sim Power of the TOST procedure obtained via simulations sampleN.HVNTID Sample size estimation for BE decision via FDA method for highly variable (HV) narrow therapeutic index drugs (NTIDs) sampleN.2TOST Sample size based on power of two TOSTs sampleN.TOST Sample size based on power of TOST sampleN.RatioF Sample size for equivalence of the ratio of two means with normality on original scale sampleN.NTIDFDA Sample size estimation for BE decision via FDA method for narrow therapeutic index drugs (NTIDs) sampleN.RSABE Sample size estimation for BE decision via linearized scaled ABE criterion CI.BE 1--2*alpha confidence interval given point estimate, CV, and n CVp2CV Decompose CV(T) and CV(R) from 'pooled' CV of T/R CV2se+se2CV+CV2mse+mse2CV Helper functions CVCL Confidence limits of a CV for log-normal data CI.RatioF 1--2*alpha Fieller CI given point est., CV (,CVb) and n OwensQOwen Owen's Q-function via repeated integration by parts OwensQ Owen's Q-function CVpooled Pooled CV from several studies CVfromCI CV from a given Confidence interval CVwRfromU CVwR from the upper expanded limit (ABEL) OwensT Owen's T-function exppower.TOST Expected power of the TOST procedure ct9.6.2+ct9.6.6 Sample Size Tables for the 2x2x3 Replicate Crossover Design ct5.1+ct5.2+ct5.3+ct5.4.1 Sample Size Tables for the Classical 2x2 Crossover Design No Results!