PowerTOST: 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.

AuthorDetlew Labes [aut, cre], Helmut Schuetz [aut], Benjamin Lang [aut]
Date of publication2016-11-01 15:20:41
MaintainerDetlew Labes <DetlewLabes@gmx.de>
LicenseGPL (>= 2)
Version1.4-3
http://github.com/Detlew/PowerTOST

View on CRAN

Man pages

bib.CL: Design matrices of period balanced incomplete block designs

CI.BE: 1-2*alpha confidence interval given point estimate, CV and n

CI.RatioF: 1-2*alpha Fieller confidence interval given point est., CV...

CV2se: Helper functions

CVCL: Confidence limits of a CV for log-normal data

CVfromCI: CV from a given Confidence interval

CVp2CV: Decompose CV(T) and CV(R) from 'pooled' CV of T/R

CVpooled: Pooled CV from several studies

data_2x2: Sample size tables for the classical 2x2 crossover

data_2x2x3: Sample size tables for the 2x2x3 replicate crossover

data_2x4x4: Sample size tables for the 2x4x4 replicate crossover

data_parallel: Sample size tables for the parallel group design

exppower.noninf: Expected power of the non-inferiority test

exppower.TOST: Expected power of the TOST procedure

expsampleN.noninf: Sample size based on expected power for the non-inferiority...

expsampleN.TOST: Sample size based on expected power

known.designs: Show the 'known' designs

OwensQ: Owen's Q-function

OwensQOwen: Owen's Q-function via repeated integration by parts

OwensT: Owen's T-function

pa.ABE: Power analysis for average bioequivalence (ABE)

pa.NTIDFDA: Power analysis for scaled ABE for NTIDs according to FDA

pa.scABE: Power analysis for scaled average bioequivalence (scABE)

power.2TOST: Power for two simultaneous TOST procedures

power.dp: Power of dose-proportionality studies evaluated via Power...

power.HVNTID: (Empirical) Power for BE decision via FDA method for highly...

power.noninf: Power of the one-sided non-inferiority t-test

power.NTIDFDA: (Empirical) Power for BE decision via FDA method for NTID's

power.RatioF: Power for equivalence of the ratio of two means with...

power.RSABE: (Empirical) Power for BE decision via linearized scaled ABE...

power.scABEL: (Empirical) Power of BE decision via scaled (widened) BE...

power.TOST: Power of the classical TOST procedure

power.TOST.sim: Power of the TOST procedure obtained via simulations

pvalue.TOST: p-value(s) of the TOST procedure

reg_const: Constructor of an object with class 'regSet' containing the...

sampleN.2TOST: Sample size based on power of 2 TOSTs

sampleN.dp: Sample size estimation of dose-proportionality studies...

sampleN.HVNTID: Sample size estimation for BE decision via FDA method for...

sampleN.noninf: Sample size for the non-inferiority t-test

sampleN.NTIDFDA: Sample size estimation for BE decision via FDA method for...

sampleN.RatioF: Sample size for equivalence of the ratio of two means with...

sampleN.RSABE: Sample size estimation for BE decision via linearized scaled...

sampleN.scABEL: Sample size estimation for BE decision via scaled (widened)...

sampleN.scABEL.ad: Sample size estimation for ABEL and iteratively adjusted...

sampleN.TOST: Sample size based on power of TOST

scABEL: Scaled (widened) BE Acceptance Limits

scABEL.ad: Iteratively adjusted alpha for ABEL

type1error.2TOST: Type I error rate for two simultaneous TOST procedures

Files in this package

PowerTOST
PowerTOST/inst
PowerTOST/inst/tests
PowerTOST/inst/tests/test_parallel.R
PowerTOST/inst/tests/test_2x2.R
PowerTOST/inst/tests/test_RatioF.R
PowerTOST/inst/tests/test_2x2x3.R
PowerTOST/inst/tests/test_2x4x2.R
PowerTOST/inst/tests/test_2x4x4.R
PowerTOST/inst/doc
PowerTOST/inst/doc/Implementation_scaledABE_sims.pdf
PowerTOST/inst/doc/BE_power_sample_size_excerpt.pdf
PowerTOST/NAMESPACE
PowerTOST/NEWS
PowerTOST/data
PowerTOST/data/data_parallel.rda
PowerTOST/data/data2x2.rda
PowerTOST/data/data2x4x4.rda
PowerTOST/data/data2x2x3.rda
PowerTOST/R
PowerTOST/R/sampleN.scABEL.ad.R PowerTOST/R/helper_exppwr.R PowerTOST/R/power.R PowerTOST/R/expSampleSize_noninf.R PowerTOST/R/BE_CI.R PowerTOST/R/power_PASS.R PowerTOST/R/CVfromCI_BL.R PowerTOST/R/Fieller.R PowerTOST/R/SampleSize_noninf.R PowerTOST/R/pa.ABE.R PowerTOST/R/power_RSABE.R PowerTOST/R/BIBs.R PowerTOST/R/power_scABEL_lo.R PowerTOST/R/power_HVNTID.R PowerTOST/R/power_RSABE_NTID.R PowerTOST/R/power_scABEL2.R PowerTOST/R/exppower.R PowerTOST/R/sampleN_2TOST.R PowerTOST/R/pa.NTID.R PowerTOST/R/scABEL.ad.R PowerTOST/R/helper_dp.R PowerTOST/R/pwrA_S3methods.R PowerTOST/R/power_type1_2TOST.R PowerTOST/R/uniroot.step.R PowerTOST/R/power_doseprop.R PowerTOST/R/samplesize_RSABE.R PowerTOST/R/OwensQOwen.R PowerTOST/R/pa.scABE.R PowerTOST/R/CVpMethods.R PowerTOST/R/samplesize_RSABE_NTID.R PowerTOST/R/samplesize_scABEL.R PowerTOST/R/critical_value_nct.R PowerTOST/R/expSampleSize.R PowerTOST/R/power_scABEL.R PowerTOST/R/helper.R PowerTOST/R/scABEL.R PowerTOST/R/CVpooled.R PowerTOST/R/power_TOST_sim.R PowerTOST/R/power_scABEL_3.R PowerTOST/R/OwensQ.R PowerTOST/R/exppower_noninf.R PowerTOST/R/SampleSize_HVNTID.R PowerTOST/R/pvalue.TOST_Benjamin.R PowerTOST/R/DesignHelpers.R PowerTOST/R/power_noninf.R PowerTOST/R/samplesize_scABEL2.R PowerTOST/R/SampleSize.R PowerTOST/R/SampleSize_doseprop.R
PowerTOST/MD5
PowerTOST/build
PowerTOST/build/partial.rdb
PowerTOST/DESCRIPTION
PowerTOST/man
PowerTOST/man/power.HVNTID.Rd PowerTOST/man/data_2x4x4.Rd PowerTOST/man/sampleN.scABEL.Rd PowerTOST/man/reg_const.Rd PowerTOST/man/power.RatioF.Rd PowerTOST/man/CVp2CV.Rd PowerTOST/man/expsampleN.TOST.Rd PowerTOST/man/OwensQ.Rd PowerTOST/man/sampleN.NTIDFDA.Rd PowerTOST/man/exppower.TOST.Rd PowerTOST/man/sampleN.RatioF.Rd PowerTOST/man/data_2x2x3.Rd PowerTOST/man/CVpooled.Rd PowerTOST/man/scABEL.Rd PowerTOST/man/pvalue.TOST.Rd PowerTOST/man/sampleN.HVNTID.Rd PowerTOST/man/CI.BE.Rd PowerTOST/man/scABEL.ad.Rd PowerTOST/man/sampleN.dp.Rd PowerTOST/man/power.TOST.Rd PowerTOST/man/power.dp.Rd PowerTOST/man/pa.ABE.Rd PowerTOST/man/data_2x2.Rd PowerTOST/man/sampleN.2TOST.Rd PowerTOST/man/sampleN.noninf.Rd PowerTOST/man/sampleN.TOST.Rd PowerTOST/man/data_parallel.Rd PowerTOST/man/power.2TOST.Rd PowerTOST/man/known.designs.Rd PowerTOST/man/OwensT.Rd PowerTOST/man/sampleN.RSABE.Rd PowerTOST/man/CI.RatioF.Rd PowerTOST/man/sampleN.scABEL.ad.Rd PowerTOST/man/pa.scABE.Rd PowerTOST/man/bib.CL.Rd PowerTOST/man/exppower.noninf.Rd PowerTOST/man/power.RSABE.Rd PowerTOST/man/power.noninf.Rd PowerTOST/man/OwensQOwen.Rd PowerTOST/man/CVCL.Rd PowerTOST/man/CVfromCI.Rd PowerTOST/man/expsampleN.noninf.Rd PowerTOST/man/power.NTIDFDA.Rd PowerTOST/man/CV2se.Rd PowerTOST/man/pa.NTIDFDA.Rd PowerTOST/man/type1error.2TOST.Rd PowerTOST/man/power.scABEL.Rd PowerTOST/man/power.TOST.sim.Rd

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