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 functions to calculate power and sample size for the BE decision
via scaled (widened) BE acceptance limits based on simulations.
Contains functions to calculate power and sample size for the
BE decision via linearized reference scaled ABE criterion according to the FDA
favored procedure based on simulations.
Contains further functions to calculate power and sample size according to the
FDA procedure for NTID's, also via simulations.Details
ll{
Package: PowerTOST
Type: Package
Version: 1.1-08
Date: 2013-12-27
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 functions for calculating 'empirical' power and sample size for scaled
average bioequivalence are power.scABEL() and sampleN.scABEL()
for the EMA adopted method via widened BE acceptance limits or
power.RSABE() and sampleN.RSABE() for the FDA favored method via
linearized scaled ABE criterion, respectively. These functions are based on
simulations.
The functions for calculating 'empirical' power and sample size via the
FDA method for NTID's are power.NTIDFDA() and sampleN.NTIDFDA().
These functions are based on simulations.
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
FDA "Draft Guidance on Progesterone"
Recommended Apr 2010; Revised Feb 2011
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM209294.pdf
Laszlo Tothfalusi and Laszlo Endrenyi
"Sample Sizes for Designing Bioequivalence Studies for Highly Variable Drugs"
J. Pharm. Pharmaceut. Sci. (www.cspsCanada.org) 15(1) 73 - 84, 2011
Tothfalusi L., Endrenyi L. and A. Garcia Arieta
"Evaluation of Bioequivalence for Highly Variable Drugs with Scaled Average
Bioequivalence"
Clin. Pharmacokin. 48/11, 725-743 (2009)
FDA "Draft Guidance on Warfarin Sodium"
Recommended Dec 2012
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM201283.pdf
BEBAC forum:
categories 'Power/Sample size' and 'R for BE/BA'
http://forum.bebac.at