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PowerTOST (version 1.3-5)

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

Description

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. ----- 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. ----- 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 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.

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Version

Install

install.packages('PowerTOST')

Monthly Downloads

1,115

Version

1.3-5

License

GPL (>= 2)

Maintainer

D. Labes

Last Published

April 12th, 2016

Functions in PowerTOST (1.3-5)

power.RSABE

(Empirical) Power for BE decision via linearized scaled ABE criterion
sampleN.2TOST

Sample size based on power of 2 TOSTs
sampleN.NTIDFDA

Sample size estimation for BE decision via FDA method for narrow therapeutic index drugs (NTID's)
known.designs

Show the 'known' designs
type1error.2TOST

Type I error rate for two simultaneous TOST procedures
power.TOST

Power of the classical TOST procedure
pa.scABE

Power analysis for scaled average bioequivalence (scABE)
power.2TOST

Power for two simultaneous TOST procedures
scABEL

Helper function to calculate the (widened) scaled BE acceptance limits
power.noninf

Power of the one-sided non-inferiority t-test
CI.RatioF

1-2*alpha Fieller confidence interval given point est., CV (,CVb) and n
PowerTOST-internal

Internal PowerTOST objects
OwensQ

Owen's Q-function
CI.BE

1-2*alpha confidence interval given point estimator, CV and n
CV2se+se2CV+CV2mse+mse2CV

Helper functions
CVp2CV

Decompose CV(T) and CV(R) from 'pooled' CV of T/R
ctSJ.VIII.10+ctSJ.VIII.20+ctCW.III

Sample size tables for the parallel group design
ct5.1+ct5.2+ct5.3+ct5.4.1

Sample size tables for the classical 2x2 crossover
power.dp

Power of dose-proportionality studies evaluated via Power model
power.NTIDFDA

(Empirical) Power for BE decision via FDA method for NTID's
bib.CL

Design matrices of period balanced incomplete block designs
power.RatioF

Power for equivalence of the ratio of two means with normality on original scale
sampleN.scABEL

Sample size estimation for BE decision via scaled (widened) BE acceptance limits
sampleN.scABEL.ad

Sample size estimation for ABEL and iteratively adjusted alpha
pa.ABE

Power analysis for average bioequivalence (ABE)
sampleN.RatioF

Sample size for equivalence of the ratio of two means with normality on original scale
power.TOST.sim

Power of the TOST procedure obtained via simulations
CVCL

Confidence limits of a CV for log-normal data
scABEL.ad

Iteratively adjusted alpha for ABEL
ct9.6.2+ct9.6.6

Sample size tables for the 2x2x3 replicate crossover
sampleN.RSABE

Sample size estimation for BE decision via linearized scaled ABE criterion
power.HVNTID

(Empirical) Power for BE decision via FDA method for highly variable NTID's
expsampleN.noninf

Sample size based on 'expected' power for the non-inferiority test
exppower.TOST

'Expected' power of TOST procedure
CVpooled

Pooled CV from several studies
ct9.6.4+ct9.6.8

Sample size tables for the 2x4x4 replicate crossover
sampleN.noninf

Sample size for the non-inferiority t-test
sampleN.HVNTID

Sample size estimation for BE decision via FDA method for highly variable (HV) narrow therapeutic index drugs (NTID's)
OwensT

Owen's T-function
CVfromCI

CV from a given Confidence interval
sampleN.dp

Sample size estimation of dose-proportionality studies evaluated via Power model
power.scABEL

(Empirical) Power for BE decision via scaled (widened) BE acceptance limits
exppower.noninf

'Expected' power of non-inferiority test
OwensQOwen

Owen's Q-function via repeated integration by parts
pvalue.TOST

p-value(s) of the TOST procedure
sampleN.TOST

Sample size based on power of TOST
expsampleN.TOST

Sample size based on 'expected' power
pa.NTIDFDA

Power analysis for scaled ABE for NTID according to FDA