Package: PowerTOST 1.5-7

PowerTOST: Power and Sample Size for (Bio)Equivalence Studies

Contains functions to calculate power and sample size for various study designs used in bioequivalence studies. Use known.designs() to see the designs supported. Power and sample size can be obtained based on different methods, amongst them prominently the TOST procedure (two one-sided t-tests). See README and NEWS for further information.

Authors:Detlew Labes [aut, cre], Helmut Schütz [aut], Benjamin Lang [aut]

PowerTOST_1.5-7.tar.gz
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manual.pdf |manual.html✨
DESCRIPTION |NEWS
card.svg |card.png
PowerTOST/json (API)

# Install 'PowerTOST' in R:
install.packages('PowerTOST', repos = c('https://detlew.r-universe.dev', 'https://cloud.r-project.org'))

Bug tracker:https://github.com/detlew/powertost/issues

Datasets:
  • ct5.1 - Sample Size Tables for the Classical 2x2 Crossover Design
  • ct5.2 - Sample Size Tables for the Classical 2x2 Crossover Design
  • ct5.3 - Sample Size Tables for the Classical 2x2 Crossover Design
  • ct5.4.1 - Sample Size Tables for the Classical 2x2 Crossover Design
  • ct9.6.2 - Sample Size Tables for the 2x2x3 Replicate Crossover Design
  • ct9.6.4 - Sample Size Tables for the 2x4x4 Replicate Crossover Design
  • ct9.6.6 - Sample Size Tables for the 2x2x3 Replicate Crossover Design
  • ct9.6.8 - Sample Size Tables for the 2x4x4 Replicate Crossover Design
  • ctCW.III - Sample Size Tables for the Parallel Group Design
  • ctSJ.VIII.10 - Sample Size Tables for the Parallel Group Design
  • ctSJ.VIII.20 - Sample Size Tables for the Parallel Group Design

On CRAN:

Conda:

9.85 score 22 stars 4 packages 180 scripts 1.4k downloads 3 mentions 60 exports 3 dependencies

Last updated from:bc54622a2d. Checks:7 WARNING, 2 OK. Indexed: yes.

TargetResultTimeFilesSyslog
linux-devel-x86_64WARNING129
source / vignettesOK211
linux-release-x86_64WARNING146
macos-release-arm64WARNING168
macos-oldrel-arm64WARNING193
windows-develWARNING102
windows-releaseWARNING92
windows-oldrelWARNING95
wasm-releaseOK135

Exports:bib.CLCI.BECI.RatioFCI2CVCV2mseCV2seCVCLCVfromCICVp2CVCVpooledCVwRfromUexppower.noninfexppower.TOSTexpsampleN.noninfexpsampleN.TOSTknown.designsmse2CVOwensQOwensQOwenOwensTpa.ABEpa.NTIDpa.scABEpower.2TOSTpower.dppower.HVNTIDpower.noninfpower.NTIDpower.RatioFpower.RSABEpower.RSABE2L.sdspower.RSABE2L.sdsimspower.scABELpower.scABEL.sdspower.scABEL.sdsimspower.TOSTpower.TOST.sdspower.TOST.simpvalue.TOSTpvalues.TOSTreg_constsampleN.2TOSTsampleN.dpsampleN.HVNTIDsampleN.noninfsampleN.NTIDsampleN.RatioFsampleN.RSABEsampleN.RSABE2L.sdssampleN.RSABE2L.sdsimssampleN.scABELsampleN.scABEL.adsampleN.scABEL.sdssampleN.scABEL.sdsimssampleN.TOSTscABELscABEL.adse2CVtype1error.2TOSTU2CVwR

Dependencies:cubaturemvtnormRcpp

Reference-Scaled Average Bioequivalence
Defaults | Sample Size | Highly Variable Drugs / Drug Products | EMA | Health Canada | Gulf Cooperation Council | FDA | Narrow Therapeutic Index Drugs (FDA, CDE) | Highly Variable Narrow Therapeutic Index Drugs (FDA, CDE) | Power | Type I Error | Iteratively adjusted α | ‘Exact’ Procedure | Helpers | BE limits | Expanded Limits (EMA, Health Canada), widened limits (GCC) | ‘Implied’ Limits | Limits of the ‘desired consumer risk model’ | Regulatory Settings | Authors | License
Rendered fromRSABE.Rmdusingknitr::rmarkdown

Last update: 2025-09-16
Started: 2019-09-01

Average Bioequivalence
Defaults | Sample size | Example 1 | Example 2 | Example 3 | Basic | Advanced | Example 4 | Example 5 | Higher-Order Designs | Power | Pooling | Hints | Power Analysis | Dropouts | Literature Data | Direction of Deviation | Authors | License
Rendered fromABE.Rmdusingknitr::rmarkdown

Last update: 2025-09-12
Started: 2019-08-30

Non-Inferiority
Example 1 | Non-Superiority | Example 2 | Bracketing Approach | Author | License
Rendered fromNI.Rmdusingknitr::rmarkdown

Last update: 2024-02-12
Started: 2019-09-21

Power Analysis
Function pa.ABE() | Function pa.scABE() | Function pa.NTIDFDA() | Examples | Average Bioequivalence | Reference-scaled Average Bioequivalence | Highly Variable Drugs / Drug Products | EMA | Health Canada | Gulf Cooperation Council | FDA, CDE | Narrow Therapeutic Index Drugs (FDA, CDE) | Cave! | Authors | License
Rendered fromPA.Rmdusingknitr::rmarkdown

Last update: 2022-02-19
Started: 2019-09-19

Dose-Proportionality
Defaults | Examples | Cave! | Author | License
Rendered fromDP.Rmdusingknitr::rmarkdown

Last update: 2022-02-16
Started: 2019-09-22

Main Vignette
Introduction | Abbreviations, Definition of Terms, Models | A Note on Rounding | Installation | Contributors | License
Rendered fromvignette.Rmdusingknitr::rmarkdown

Last update: 2022-02-14
Started: 2019-08-30

Readme and manuals

Help Manual

Help pageTopics
Design matrices of period balanced incomplete block designsbib.CL
1-2*alpha confidence interval given point estimate, CV, and nCI.BE
1-2*alpha Fieller CI given point estimate, CV (, CVb) and nCI.RatioF
Sample Size Tables for the Classical 2x2 Crossover Designct5.1 ct5.2 ct5.3 ct5.4.1 data2x2
Sample Size Tables for the 2x2x3 Replicate Crossover Designct9.6.2 ct9.6.6 data2x2x3
Sample Size Tables for the 2x4x4 Replicate Crossover Designct9.6.4 ct9.6.8 data2x4x4
Sample Size Tables for the Parallel Group DesignctCW.III ctSJ.VIII.10 ctSJ.VIII.20 data_parallel
Helper functionsCV2mse CV2se mse2CV se2CV
Confidence limits of a CV for log-normal dataCVCL
CV from a given Confidence intervalCI2CV CVfromCI
Decompose CV(T) and CV(R) from 'pooled' CV of T/RCVp2CV
Pooled CV from several studiesCVpooled print.CVp
CVwR from the upper expanded limit (ABEL)CVwRfromU U2CVwR
Removed functions in PowerTOSTdefunct
Deprecated functions in PowerTOSTdeprecated
Expected power of the non-inferiority testexppower.noninf
Expected power of the TOST procedureexppower.TOST
Sample size based on expected power for the non-inferiority testexpsampleN.noninf
Sample size based on expected powerexpsampleN.TOST
Show the 'known' designsknown.designs
Owen's Q-functionOwensQ
Owen's Q-function via repeated integration by partsOwensQOwen
Owen's T-functionOwensT
Power analysis for average bioequivalence (ABE)pa.ABE plot.pwrA print.pwrA
Power analysis for scaled ABE for NTIDspa.NTID pa.NTIDFDA
Power analysis for scaled average bioequivalence (scABE)pa.scABE
Power for two simultaneous TOST procedurespower.2TOST
Power of dose-proportionality studies evaluated via Power modelpower.dp
(Empirical) Power for BE decision via FDA method for highly variable NTIDspower.HVNTID
Power of the one-sided non-inferiority t-testpower.noninf
(Empirical) Power for BE decision via FDA method for NTIDspower.NTID power.NTIDFDA
Power for equivalence of the ratio of two means with normality on original scalepower.RatioF
(Empirical) Power for BE decision via linearized scaled ABE criterionpower.RSABE
(Empirical) Power of BE Decision via Reference Scaled ABEpower.RSABE2L.sds power.RSABE2L.sdsims
(Empirical) Power of BE decision via scaled (widened) BE acceptance limitspower.scABEL
(Empirical) Power of BE decision via scaled (widened) BE acceptance limitspower.scABEL.sds power.scABEL.sdsims
Power of the classical TOST procedurepower.TOST
Power calculation of the BE decision with models incorporating groupspower.TOST.sds
Power of the TOST procedure obtained via simulationspower.TOST.sim
p-value(s) of the TOST procedurepvalue.TOST pvalues.TOST
Constructor of an object with class 'regSet' containing the regulatory settings for ABELreg_const
Sample size based on power of two TOSTssampleN.2TOST
Sample size estimation of dose-proportionality studies evaluated via the power modelsampleN.dp
Sample size estimation for BE decision via FDA method for highly variable (HV) narrow therapeutic index drugs (NTIDs)sampleN.HVNTID
Sample size for the non-inferiority t-testsampleN.noninf
Sample size estimation for BE decision via the FDA's method for narrow therapeutic index drugs (NTIDs)sampleN.NTID sampleN.NTIDFDA
Sample size for equivalence of the ratio of two means with normality on original scalesampleN.RatioF
Sample size estimation for BE decision via linearized scaled ABE criterionsampleN.RSABE
Sample size estimation for BE Decision via Reference Scaled ABEsampleN.RSABE2L.sds sampleN.RSABE2L.sdsims
Sample size estimation for BE decision via scaled (expanded) BE acceptance limitssampleN.scABEL
Sample size estimation for ABEL and iteratively adjusted alphasampleN.scABEL.ad
Sample size estimation for BE decision via scaled (expanded) BE acceptance limitssampleN.scABEL.sds sampleN.scABEL.sdsims
Sample size based on power of TOSTsampleN.TOST
Scaled (widened) BE Acceptance LimitsscABEL
Iteratively adjusted alpha for ABELscABEL.ad
Type I error rate for two simultaneous TOST procedurestype1error.2TOST