PowerTOST v1.5-7

Bug fixes

• in nvec() regarding splitting total sample size into vector of subjects per sequence

PowerTOST v1.5-6

Bug fixes

• Bug fixed in CI.BE() regarding cases with only Ntotal given.

Minor changes

• Function shadowtext() lifted from package TeachingDemos and recoded since TeachingDemos was orphaned (request of Brian Ripley). Orphaned status later on abandoned but nevertheless the recoded function used furthermore.
• Updated the RSABE-vignette and the Man page of sampleN.scABEL() to reflect the GCC guidelines (Version 3.1 of 10 August 2022).
• Example results in man pages of functions power.2TOST() and SampleN.2TOST() corrected.

Major changes

• Argument p.level in function power.TOST.sds() introduced to make the significance level of the group-by-treatment interaction test variable. Was former hard coded to 0.1.
• The name of functions dealing with the FDA methods for NTID are now without the acronym FDA in their names since the evaluation methods requested by the FDA are also required by China CDE. These functions are power.NTID(), sampleN.NTID(), and pa.NTID(). See NEWS under PowerTOST 1.5-4.

PowerTOSTv1.5-4

Bug fixes

• Incomplete HTML-entities in 3 man pages corrected (request of Kurt Hornik).
• Fix in power.TOST() w.r.t vectorization of CV or theta0.

Minor changes

• Example with vectorized sampleN.TOST() added to vignette ABE; vignette PA adapted to pa.NTID().
• URLs in README and man pages updated.
• Coefficients with more decimals (15) for the 10-point Gauss quadrature in function tfn(). Thanks to PharmCat for contributing them.
• Clarification of the calculations with gmodel = 1 in the man page section Details of function power.TOST.sds().

Major changes

• Functions dealing with the FDA method for NTID have now aliases without FDA in their names since the evaluation methods requested by the FDA are also required by China CDE.
  The aliases are power.NTID(), sampleN.NTID(), and pa.NTID().
  The former functions power.NTIDFDA(), sampleN.NTIDFDA(), and pa.NTIDFDA() are deprecated and will be removed in the next release.

PowerTOSTv1.5-3

On CRAN 2021-01-18.

Major changes

• scABEL.ad() and sampleN.scABEL.ad() adapted to deal with regulator = "GCC".
  Man pages, README, and RSABE-vignette updated accordingly.
• Regulator "GCC" introduced (GCC = Co-operation Council for the Arab States
  of the Gulf). The GCC evaluation framework for HVD / HVDP is/can be
  treated as a special case of ABEL, i.e., use the regulatory settings with
  power.scABEL() or sampleN.scABEL().

PowerTOST v1.5-2

On CRAN 2020-10-27.

Bug fixes

• stringsAsFactors = FALSE in example of main vignette for R v<4.0.0.
  stringsAsFactors = TRUE (default) for a data.frame gave an error on Mac OSX oldrelease with R 3.6.3 (outdated version)

PowerTOST V1.5-1

On CRAN 2020-10-22

Bug fixes

• Check of arg theta0 within range theta1 ... theta2 fixed.
• Fix of the default settings of theta1, theta2 if missing in various functions.
• Added emmeans to Suggests. Otherwise NOTE on r-devel-linux-x86_64-fedora-clang.
  THX to Gábor Csárdi and Duncan Murdoch on r-package-devel. Will be required in R4.1.0 released next year.

Minor changes

• Added example for statistical assurance to the ABE-Vignette.
• More checks of CV and theta0 vectorized input to power.TOST(). Only one argument may be a vector.
• Unified man pages of sampleN.*: Always estimation instead of calculation. References added for Fieller’s CI.
• More examples in README.
• Changed http(s) locations of References according to R CMD check.
• Cosmetics in Vignettes. Added examples for logscale = FALSE to the ABE-Vignette.
• Changed http(s) locations of References according to R CMD check.
• Cosmetics in Vignettes. Added examples for logscale = FALSE to the ABE-Vignette.

PowerTOST v1.5-0

PowerTOST 1.5-0

(Maintenance release dedicated to 70 birthday of Detluuu)

On CRAN 2020-08-09.

Bug fixes

• Bug fix in scABEL.ad w.r.t. coercion
• Fix of the link to package emmeans in man pages of expected power.
• Fix in Example 1 of ABE.Rmd (not a good idea specify a variable with the same name as a function).

Major changes

• Pre-compiled RSABE vignette.

Minor changes

• Highlight clarification about total sample size in vignettes.
• Removed links to man-pages in vignettes (they work in the library but not in the public ones on CRAN).
• Moved tufte from Imports to Suggests (Duncan Murdoch).
• Harmonize default value of theta1 in pvalue.TOST in case of logscale = FALSE
• Clarification of argument CV (and theta0, theta1, theta2) in case of logscale = FALSE.
• Clarify in man-pages that all functions return the total sample size (and not subjects/sequence in crossovers and subjects/group in parallel designs -- like in some other software packages). Suggested by Amandine Schmutz.

V1.4-9

PowerTOST 1.4-9

Submitted to CRAN 2019-12-16. (xmas gift)

Bug fixes

• Fix in power.dp() w.r.t. setting argument CVb if missing in case of design="IBD".
• Fix in scABEL.ad(): reg$name instead of regulator.
• CV in 4th panel of pwrA_S3methods.R to the same precison like in the others.
• Fix in power.TOST.sds() for gmodel=1, case of gmodel=3 with data of the largest group (group by treatment interaction significant at p=0.1)

Major changes

• (Pre-compiled) vignettes.

Minor changes

• Imports package tufte for nice quotes in Rmarkdown.
• Slightly enhanced man pages of power.dp() and sampleN.dp() w.r.t. the value of CVb in case of design="IBD".
• Cosmetics in output of sampleN.noninf based on margin.
• Reworked minimum sample sizes in pa.scABE.R() according to guidances. Generally 12 (as before) but 24 for the FDA. Also 24 for the EMA if 2x2x3 design (Q&A document). Changed N to n in the S3-methods in conformity with other functions.

PowerTOST v1.4-8

Bug fixes

• scABEL.ad(), sampleN.scABEL.ad(): CVwT was not given in output if CVwas a vector.
• In scABEL.ad.R regulatorwas NULL. Corrected to reg$name.
• Smaller font in 4^th screen of pwrA_S3methods.R of pa.NTID() (more lines required). Plain font instead of bold in main.
• Broken FDA URL in many man pages corrected.
• In expsampleN.noninf() wrt operator && with vector arguments (new check in R 3.6.0).
• CI.RatioF() fixed. Thanks to Michael (mittyri).

Major changes

• New function sampleN.RSABE2L.sdsims() for sample size estimation via subject simulations for the ‘exact’ method of Tóthfalusi & Endrényi “Algorithms for evaluating reference scaled average bioequivalence: power, bias, and consumer risk”.
• New function sampleN.scABEL.sdsims() for sample size estimation for ABEL via subject simulations. Useful in case of assumed heteroscedasticity in the partial replicate design (TRT|RTR|RRT).
• NEWS.md instead of NEWS.
• README.md (knitted from README.Rmd).
• Function power.TOST.sds() to simulate subject data & evaluate via models with group effect implemented.
• Unified Code base for the scaled ABE functions.

Minor changes

• LaTeX-builder on CRAN laments about UTF-8 charcters in man-pages. No problem rendering the PDF-manual locally! Replaced all UTF-8 characters by \enc{foo}{bar}.
• In power.scABEL(): If nsims not given, defaults to 1e5 (like before). If theta0 equals one of the expanded limits, deafault s to 1e6. Man-page updated.
• Output of sampleN.TOST(): Same name of replicate designs like in the scaled functions.
• In power.scABEL() name of scaled component "p(BE-ABEL)" instead of "p(BE-wABEL)".
• Updated test_ABEL.R in inst/tests to support subject simulations.
• power.scABEL(): More informative warning about heteroscedasticity in the partial replicate design (use of power.scABEL.sdsims() suggested).
• Add/subtract .Machine$double.eps if rho is -1 or +1 given in power_type1_2TOST.R (similar to sampleN_2TOST_sim.R). Removed warning in the latter function. Less confusing for users and the example in the man-page looks nicer.
• Man pages reworked.

PowerTOST v1.4-7

• Bug corrected in functions using expected power
• Function type1error.2TOST() no longer available since it suffers from
  insufficient precision to obtain the type 1 error (TIE) via simulations.
  Due to the intersection-union principle the TIE is always upper bounded
  to alpha by theory.
• Function power.2TOST() now based on simulations to obtain the power
  of 2 TOSTs (statistical flaw in 4-dimensional t-distribution approach).
• sampleN.2TOST and man page adapted according to this change.
• regulator="FDA" implemented in scABEL.ad().
• New function power.RSABE2L.sds() which implements the 'exact' based
  method for RSABE (ncTOST) of the two Laszlos. Documentation included.