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.

Install the latest version of this package by entering the following in R:

`install.packages("PowerTOST")`

Author | Detlew Labes [aut, cre], Helmut Schuetz [aut], Benjamin Lang [aut] |

Date of publication | 2017-03-16 12:24:29 |

Maintainer | Detlew Labes <DetlewLabes@gmx.de> |

License | GPL (>= 2) |

Version | 1.4-4 |

http://github.com/Detlew/PowerTOST |

**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 NTIDs

**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.scABEL.sdsims:** (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

bib.CL | Man page |

CI2CV | Man page |

CI.BE | Man page |

CI.RatioF | Man page |

ct5.1 | Man page |

ct5.2 | Man page |

ct5.3 | Man page |

ct5.4.1 | Man page |

ct9.6.2 | Man page |

ct9.6.4 | Man page |

ct9.6.6 | Man page |

ct9.6.8 | Man page |

ctCW.III | Man page |

ctSJ.VIII.10 | Man page |

ctSJ.VIII.20 | Man page |

CV2mse | Man page |

CV2se | Man page |

CVCL | Man page |

CVfromCI | Man page |

CVp2CV | Man page |

CVpooled | Man page |

data2x2 | Man page |

data2x2x3 | Man page |

data2x4x4 | Man page |

data_parallel | Man page |

exppower.noninf | Man page |

exppower.TOST | Man page |

expsampleN.noninf | Man page |

expsampleN.TOST | Man page |

known.designs | Man page |

mse2CV | Man page |

OwensQ | Man page |

OwensQOwen | Man page |

OwensT | Man page |

pa.ABE | Man page |

pa.NTIDFDA | Man page |

pa.scABE | Man page |

plot.pwrA | Man page |

power.2TOST | Man page |

power.dp | Man page |

power.HVNTID | Man page |

power.noninf | Man page |

power.NTIDFDA | Man page |

power.RatioF | Man page |

power.RSABE | Man page |

power.scABEL | Man page |

power.scABEL.sdsims | Man page |

power.TOST | Man page |

power.TOST.sim | Man page |

print.CVp | Man page |

print.pwrA | Man page |

pvalues.TOST | Man page |

pvalue.TOST | Man page |

reg_const | Man page |

sampleN.2TOST | Man page |

sampleN.dp | Man page |

sampleN.HVNTID | Man page |

sampleN.noninf | Man page |

sampleN.NTIDFDA | Man page |

sampleN.RatioF | Man page |

sampleN.RSABE | Man page |

sampleN.scABEL | Man page |

sampleN.scABEL.ad | Man page |

sampleN.TOST | Man page |

scABEL | Man page |

scABEL.ad | Man page |

se2CV | Man page |

type1error.2TOST | Man page |

inst

inst/tests

inst/tests/test_parallel.R
inst/tests/test_2x2.R
inst/tests/test_RatioF.R
inst/tests/test_2x2x3.R
inst/tests/test_2x4x2.R
inst/tests/test_2x4x4.R
inst/doc

inst/doc/Implementation_scaledABE_sims.pdf

inst/doc/BE_power_sample_size_excerpt.pdf

inst/doc/Expected_Power_for_TOST.pdf

NAMESPACE

NEWS

data

data/data_parallel.rda

data/data2x2.rda

data/data2x4x4.rda

data/data2x2x3.rda

R

R/sampleN.scABEL.ad.R
R/helper_exppwr.R
R/power.R
R/expSampleSize_noninf.R
R/BE_CI.R
R/power_PASS.R
R/CVfromCI_BL.R
R/Fieller.R
R/SampleSize_noninf.R
R/pa.ABE.R
R/power_scABEL_sdsims.R
R/power_RSABE.R
R/BIBs.R
R/power_scABEL_lo.R
R/power_HVNTID.R
R/power_RSABE_NTID.R
R/power_scABEL2.R
R/exppower.R
R/sampleN_2TOST.R
R/simulate_replicate_fixed.R
R/pa.NTID.R
R/scABEL.ad.R
R/helper_dp.R
R/pwrA_S3methods.R
R/power_type1_2TOST.R
R/uniroot.step.R
R/power_doseprop.R
R/samplesize_RSABE.R
R/OwensQOwen.R
R/power_scABEL_0.R
R/pa.scABE.R
R/CVpMethods.R
R/samplesize_RSABE_NTID.R
R/power_scABEL1.R
R/samplesize_scABEL.R
R/critical_value_nct.R
R/expSampleSize.R
R/power_scABEL.R
R/helper.R
R/scABEL.R
R/CVpooled.R
R/power_TOST_sim.R
R/OwensQ.R
R/exppower_noninf.R
R/SampleSize_HVNTID.R
R/pvalue.TOST_Benjamin.R
R/DesignHelpers.R
R/power_noninf.R
R/samplesize_scABEL2.R
R/SampleSize.R
R/SampleSize_doseprop.R
MD5

build

build/partial.rdb

DESCRIPTION

man

man/power.HVNTID.Rd
man/data_2x4x4.Rd
man/sampleN.scABEL.Rd
man/reg_const.Rd
man/power.RatioF.Rd
man/CVp2CV.Rd
man/expsampleN.TOST.Rd
man/OwensQ.Rd
man/sampleN.NTIDFDA.Rd
man/exppower.TOST.Rd
man/sampleN.RatioF.Rd
man/data_2x2x3.Rd
man/CVpooled.Rd
man/scABEL.Rd
man/pvalue.TOST.Rd
man/sampleN.HVNTID.Rd
man/CI.BE.Rd
man/power.scABEL.sdsims.Rd
man/scABEL.ad.Rd
man/sampleN.dp.Rd
man/power.TOST.Rd
man/power.dp.Rd
man/pa.ABE.Rd
man/data_2x2.Rd
man/sampleN.2TOST.Rd
man/sampleN.noninf.Rd
man/sampleN.TOST.Rd
man/data_parallel.Rd
man/power.2TOST.Rd
man/known.designs.Rd
man/OwensT.Rd
man/sampleN.RSABE.Rd
man/CI.RatioF.Rd
man/sampleN.scABEL.ad.Rd
man/pa.scABE.Rd
man/bib.CL.Rd
man/exppower.noninf.Rd
man/power.RSABE.Rd
man/power.noninf.Rd
man/OwensQOwen.Rd
man/CVCL.Rd
man/CVfromCI.Rd
man/expsampleN.noninf.Rd
man/power.NTIDFDA.Rd
man/CV2se.Rd
man/pa.NTIDFDA.Rd
man/type1error.2TOST.Rd
man/power.scABEL.Rd
man/power.TOST.sim.Rd
Questions? Problems? Suggestions? Tweet to @rdrrHQ or email at ian@mutexlabs.com.

Please suggest features or report bugs with the GitHub issue tracker.

All documentation is copyright its authors; we didn't write any of that.

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