# PowerTOST v1.4-7

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## 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.
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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 | |

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## Last month downloads

## Details

Type | Package |

Date | 2018-04-12 |

ByteCompile | yes |

LazyData | true |

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

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

License | GPL (>= 2) |

NeedsCompilation | no |

Packaged | 2018-04-12 19:09:40 UTC; Detlew |

Repository | CRAN |

Date/Publication | 2018-04-12 19:43:08 UTC |

suggests | crossdes |

imports | cubature (>= 1.3-6) , graphics , grDevices , mvtnorm , stats , TeachingDemos , utils |

Contributors | Helmut Schuetz, Benjamin Lang |

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