Learn R Programming

⚠️There's a newer version (1.5-6) of this package.Take me there.

PowerTOST (version 1.4-6)

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 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.

Copy Link

Version

Install

install.packages('PowerTOST')

Monthly Downloads

1,076

Version

1.4-6

License

GPL (>= 2)

Issues

Pull Requests

Stars

Forks

Maintainer

D. Labes

Last Published

August 17th, 2017

Functions in PowerTOST (1.4-6)

CVfromCI

CV from a given Confidence interval
CVp2CV

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

Owen's Q-function
OwensQOwen

Owen's Q-function via repeated integration by parts
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 (,CVb) and n
CV2se+se2CV+CV2mse+mse2CV

Helper functions
CVCL

Confidence limits of a CV for log-normal data
CVpooled

Pooled CV from several studies
CVwRfromU

CVwR from the upper expanded limit (ABEL)
expsampleN.TOST

Sample size based on expected power
expsampleN.noninf

Sample size based on expected power for the non-inferiority test
ct5.1+ct5.2+ct5.3+ct5.4.1

Sample Size Tables for the Classical 2x2 Crossover Design
ct9.6.2+ct9.6.6

Sample Size Tables for the 2x2x3 Replicate Crossover Design
ct9.6.4+ct9.6.8

Sample Size Tables for the 2x4x4 Replicate Crossover Design
ctSJ.VIII.10+ctSJ.VIII.20+ctCW.III

Sample Size Tables for the Parallel Group Design
known.designs

Show the 'known' designs
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.scABEL.sdsims

(Empirical) Power of BE decision via scaled (widened) BE acceptance limits
OwensT

Owen's T-function
bib.CL

Design matrices of period balanced incomplete block designs
power.NTIDFDA

(Empirical) Power for BE decision via FDA method for NTIDs
power.RSABE

(Empirical) Power for BE decision via linearized scaled ABE criterion
reg_const

Constructor of an object with class 'regSet' containing the regulatory settings for ABEL
exppower.TOST

Expected power of the TOST procedure
exppower.noninf

Expected power of the non-inferiority test
power.2TOST

Power for two simultaneous TOST procedures
power.HVNTID

(Empirical) Power for BE decision via FDA method for highly variable NTIDs
sampleN.HVNTID

Sample size estimation for BE decision via FDA method for highly variable (HV) narrow therapeutic index drugs (NTIDs)
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
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
power.dp

Power of dose-proportionality studies evaluated via Power model
sampleN.TOST

Sample size based on power of TOST
sampleN.dp

Sample size estimation of dose-proportionality studies evaluated via Power model
pvalue.TOST

p-value(s) of the TOST procedure
scABEL.ad

Iteratively adjusted alpha for ABEL
type1error.2TOST

Type I error rate for two simultaneous TOST procedures
sampleN.2TOST

Sample size based on power of 2 TOSTs
sampleN.scABEL.ad

Sample size estimation for ABEL and iteratively adjusted alpha
scABEL

Scaled (widened) BE Acceptance Limits
power.RatioF

Power for equivalence of the ratio of two means with normality on original scale
power.TOST

Power of the classical TOST procedure
power.noninf

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

(Empirical) Power of BE decision via scaled (widened) BE acceptance limits
sampleN.noninf

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

Sample size estimation for BE decision via scaled (widened) BE acceptance limits