PowerTOST-package: Power and sample size based on two one-sided t-test (TOST) procedure
for bioequivalence 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).
These functions are intended for studies with clinical endpoints.
Contains further functions for power and sample size calculations based on
non-inferiority test.
This is not a TOST procedure (but rather OOST ;-)) but eventually useful if the
question of 'non-superiority' must be evaluated within a BE study.
The power and sample size calculations based on non-inferiority test may also
performed via 'expected' power in case of uncertain (estimated) variability.
Contains now functions power.scABEL() and sampleN.scABEL() to calculate
power and sample size for the BE decision via scaled (widened) BE acceptance
limits based on simulations.Details
ll{
Package: PowerTOST
Type: Package
Version: 1.1-00
Date: 2013-02-08
License: GPL (>=2)
LazyLoad: yes
LazyData: yes
}
Main functions are sampleN.TOST() and power.TOST() for usual
power and sample size calculations.
If you prefer sample size based on 'expected' power see the functions
expsampleN.TOST() and exppower.TOST().
The main functions for equivalence of the ratio of means with normality on the
original scale are power.RatioF() and sampleN.RatioF().
The functions for calculating power and sample size for the non-inferiority case
are power.noninf() and sampleN.noninf().
The functions for calculating 'expected' power and sample size for the
non-inferiority case are exppower.noninf() and expsampleN.noninf().
The package contains further some utility functions (see Index).References
Phillips, K. F. (1990)
"Power of the Two One-Sided Tests Procedure in Bioequivalence"
Journal of Pharmacokinetics and Biopharmaceutics, 18, 137-144.
Diletti, D., Hauschke, D., and Steinijans, V. W. (1991)
"Sample Size Determination for Bioequivalence Assessment
by Means of Confidence Intervals"
Int. J. of Clinical Pharmacology, Therapy and Toxicology, 29, 1-8
S.A. Julious, R.J. Owen (2006)
"Sample size calculations for clinical studies allowing for
uncertainty in variance"
Pharmaceutical Statistics (2006), 5, 29-37
S.A. Julious (2010)
"Sample sizes for Clinical Trials"
CRC Press, Chapman & Hall 2010
Hauschke D., Kieser M., Diletti E. and Burke M. (1999)
"Sample size determination for proving equivalence based on the ratio
of two means for normally distributed data"
Stat. Med. 18(1) p93-105 (1999)
Hauschke D., Steinijans V. and Pigeot I.
"Bioequivalence studies in Drug Development"
John Wiley & Sons, Chichester (2007)
Chapter 5 and 10.3
BEBAC forum:
categories 'Power/Sample size' and 'R for BE/BA'
http://forum.bebac.at