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

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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.

Author
Detlew Labes [aut, cre], Helmut Schuetz [aut], Benjamin Lang [aut]
Date of publication
2016-11-01 15:20:41
Maintainer
Detlew Labes <DetlewLabes@gmx.de>
License
GPL (>= 2)
Version
1.4-3
URLs

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