NEWS.md

PowerTOST 1.5-6

On CRAN submitted 2024-03-18.

Bug fixes

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

Minor changes

• Function shadowtext() lifted from package TeachingDemos and recoded since TeachingDemoswas 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.

PowerTOST 1.5-5

Never on CRAN, only a development version.

PowerTOST 1.5-4

On CRAN 2022-02-21.

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.

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 functions power.NTIDFDA(), sampleN.NTIDFDA(), and pa.NTIDFDA() are deprecated and will be removed in the next release.

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().

PowerTOST 1.5-3

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 1.5-2

On CRAN 2020-10-27.

Bug fixes

• stringsAsFactors = FALSE in example of main vignette for R <4.0.0.

PowerTOST 1.5-1

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 @r-pkg-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.

PowerTOST 1.5-0

On CRAN 2020-08-09. (Maintenance release dedicated to 70 birthday of Detluuu)

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 to assign 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 @r-pkg-devel).
• 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 and vignettes 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.

PowerTOST 1.4-9

On CRAN 2019-12-19. (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 1.4-8

On CRAN 2019-08-29.

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 characters 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, defaults 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 1.4-7

On CRAN 2018-04-12 (dedicated to the birthday of Alfie Schütz. :-)

Bug fixes

• Correction in functions using expected power.

Major changes

• 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() 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.
• Argument regulator="FDA" implemented in scABEL.ad().
• New function power.RSABE2L.sds() which implements the 'exact' based method for RSABE (ncTOST) of the two Lászlós. Documentation included.

PowerTOST 1.4-6

On CRAN 2017-08-17.

Bug fixes

• Functions relying on simulations if nsims > 1e7.

Major changes

• Functions CVwRfromU() / U2CVwR() to calculate CV_wR from the upper expanded limit of an ABEL study according to the EMA’s or Health Canada’s rules.
• Power and sample size for TOST: Argument alpha restricted to scalar. Internal functions now allow length = 2 (different alphas for the two null hypotheses).
• Deprecated argument dfCV in expected power functions completely removed.

Minor changes

• Man-pages for non-inferiority again updated.
• Data lazy loading (allows access by the name).

PowerTOST 1.4-5

On CRAN 2017-05-19.

Bug fixes

• power.scABEL.sdsims() fixed which gave power=NA if alpha=0.
• Correction in sampleN.scABEL.ad() if pre-specified alpha gives TIE <0.05.
• Small bug in the S3 method plot for class 'pwrA' corrected (text in the 4^th screen was truncated on top if saved as a PDF). Replaced text() by TeachingDemos::shadowtext() to enhance legibility (interfered with underlying grid before).

Major changes

• Two new test scripts in /test subdirectory added: test_ABEL.R and test_RSABE.R which recalculate the sample size tables given in Tóthfalusi & Endrényi “Sample Sizes for Designing Bioequivalence Studies for Highly Variable Drugs”. Contributed by Helmut.
• power.scABEL.sdsims() now has an argument design_dta to specify the design via a data.frame. May be useful for considering missing data.
  Attention! This feature is experimental because the data.frame is currently not checked.
• Updated functions scABEL.ad() and sampleN.scABEL.ad() to allow subject data simulations via power.scABEL.sdsims() if regulator = "EMA". Removed regulator = "ANVISA". Changed the order of sequences to be consistent with the other functions of PowerTOST.
• Removed regulator = "ANVISA" from pa.scABE().

Minor changes

• Man-pages for non-inferiority functions updated to include a description of the underlying hypotheses.
• Remaining man-pages updated where term 'Null (true) ratio' was mentioned instead of 'True ratio'.
• Internal change of coding in design helpers (repeated creation of data.frame with design characteristics avoided).
• Typo corrected in Expected_Power_for_TOST.pdf.
• Renamed the variable 'adj. alpha' in sampleN.scABEL.ad() to 'alpha.adj'for consistency with scABEL.ad().

PowerTOST 1.4-4

On CRAN 2017-03-15.

Bug fixes

• Use of removed functions power.scABEL2() and sampleN.scABEL2() in pa.scABE() corrected.

Major changes

• Added function power.scABEL.sdsims() to calculate power for the BE decision via scaled (widened) BE acceptance limits (EMA recommended) based on subject data simulations.
• Removed default CV = 0.3 from scABEL.ad() and sampleN.scABEL.ad(). Stops execution if CV not specified.

Minor changes

• Administrative change for expected power: cubature::adaptIntegrate replaced by cubature::hcubature to reflect change of function name within package cubature.
• Low CV (cosmetic) correction in power.scABEL() introduced.
• DOI for references added in many man-pages. THX to Helmut.
• Ben’s description of expected power added in /doc subdirectory.
• BE_power_sample_size_excerpt.pdf updated to reflect the changes in computation of OwensQ.

PowerTOST 1.4-3

On CRAN 2016-11-01.

Bug fixes

• Little bug in power.TOST() removed which caused power <0 for large degrees of freedom.
• Little inconsistency resolved (by Helmut) in output of power analysis functions w.r.t. ratio or percent. Thanks to user myttiri of the BEBA forum for pointing out this inconsistency.

Major changes

• Functions for expected power of the TOST procedure and sample size based on expected power reworked to deal also with uncertainty of theta0 or dealing with both uncertainties of CV and theta0. Contributed mainly by Benjamin Lang.
• Deprecated functions power.scABEL2() and sampleN.scABEL2() removed.
• regulator = "ANVISA" no longer allowed in the scaled ABEL functions.
• OwensQ() simpler/faster implemented. Now based solely on numerical integration in combination with non-central t.
• Owen’s T-function, used in OwensQOwen() now based on algorithm AS76 and remarks to that algorithm to avoid numeric errors of the implementation via integrate().

Minor changes

• Data.frame ct9.6.6 in data("data2x2x3") added which was missing since a long time ago.

PowerTOST 1.4-2

On CRAN 2016-07-14.

Bug fixes

• Minor bug in sampleN.2TOST() fixed.

Major changes

• Deprecated argument point in functions CI2CV()/CVfromCI() removed.

Minor changes

• Implementation_scaledABE_sims.pdf in /doc subdirectory updated to reflect changes in code of the scaled ABE functions.
• The S3 method plot for class 'pwrA' now has an argument ratiolabel for labeling the axis concerning theta0. Wish of Benjamin Lang.
• Various enhancements in man-pages.
• Power and sample size for FDA RSABE now take into account a CVcap if defined as finite.
• Misleading term 'Null (true) ratio' in output of sample size functions changed to 'True ratio'.

PowerTOST 1.4-1

Published on GitHub 2016-06-14.

Major changes

• Objects of class 'regSet' have an additional component 'est_method' which controls the simulations via key statistics of the evaluation using the EMA’s ANOVA or the FDA’s recommended ISC in xyz.scABEL() functions.
• power.scABEL()/power.scABEL2() as well as sampleN.scABEL()/sampleN.scABEL2() are now unified. The regulator component 'est_method' is used for switching between simulations based on the EMA’s ANOVA evaluation or ISC evaluation, respectively.
  power.scABEL2()/sampleN.scABEL2() are therefore deprecated and will be removed in future versions. A corresponding warning is thrown.

Minor changes

• URL of PowerTOST on GitHub added, URL for bug reports added to DESCRIPTION.

PowerTOST 1.3-7

Published on GitHub 2016-06-10.

Bug fixes

• In functions scABEL.ad() and sampleN.scABEL.ad() if former argument regulator="ANVISA" settings are used.

PowerTOST 1.3-6

On CRAN 2016-06-06.
Released to beta-testers 2016-05-04.

Major changes

• Functions for power and sample size of BE decision of highly variable drugs or drug products via ABEL (average BE with expanding limits) updated to incorporate the regulatory settings of Health Canada (new functions power.scABEL2() and sampleN.scABEL2() based on simulations of intra-subject contrasts evaluation).
• The same functions now accept as regulator argument an object of class 'regSet' and allow via this way User definitions of regulatory settings.
• New function reg_const made visible to define objects of 'regSet'. Class 'regSet' has an S3 print method.

Minor changes

• Default value of argument theta0 in functions power.scABEL(), power.scABEL2() and power.RSABE() changed to 0.90 to be in agreement with the setting in the corresponding sample size functions.
• Function scABEL() (calculation of widened acceptance limits) no longer accepts regulator="USER". This case may be handled via an object with class 'regSet', as defined by help of function reg_const().
• Functions CVfromCI()/CI2CV now use pe instead of point as argument due to more consistency with their dual CI.BE(). For backward compatibility point may be used also but then a warning is thrown. Argument point will be removed in future versions.
• Functions for expected power for TOST and non-inferiority updated to avoid numeric dificulties with integrate() if method="exact".
• Documentation (typos in man-pages) rigorously enhanced. Thanks to Helmut and Ben.

PowerTOST 1.3-5

On CRAN 2016-04-12.

Bug fixes

• plot method of 'pwrA' objects reworked by Helmut Schütz to avoid some ugly overlays.

Major changes

• Functions for expected power for TOST and non-inferiority updated (including corresponding sample size functions). Functions now include an exact method which calculates the expected value of the power with respect to the (prior) distribution of σ² (inverse Γ distribution). Formerly only an approximation according to Julious/Owen was implemented. Contributed by Benjamin Lang.

Minor changes

• The functions for iteratively adjusting alpha for the EMA recommended ABEL method now have a new argument tol for convergence tolerance of the internally used uniroot(). It was formerly hardcoded as tol=1e-5. Contributed by Helmut Schütz.

PowerTOST 1.3-4

On CRAN 2016-03-09.

Bug fixes

• In all sample size estimation functions for scaled ABE which resulted in NA for sample size for very low variability. Thanks to Shuanghe for detecting this bug.

Minor changes

• All functions for scaled ABE now have an argument imax=100 for the maximum number of steps for sample size search. Wish of Helmut Schütz.

PowerTOST 1.3-3

On CRAN 2016-01-15.
Released 2016-01-04 to alpha testers.

Major changes

• New functions scABEL.ad() and sampleN.scABEL.ad() to iteratively adjust α in order to control the consumer risk and adapt the sample size to compensate for a potential loss in power with the EMA method of scaled ABE (ABEL). Contributed by Helmut Schütz.

Minor changes

• Default theta0 changed to 0.9 in sample size estimation for scaled ABE (as recommended by the two Lászlós).

PowerTOST 1.3-2

On CRAN 2015-12-02.

Major changes

• New functions for calculation of power, type 1 errror and sample size for 2 TOST instances. Contributed by Benjamin Lang.

PowerTOST 1.3-1

On CRAN 2015-09-30.
Released 2015-09-23 to alpha testers.

Major changes

• New functions power.HVNTID() and sampleN.HVNTID() introduced to calculate power and sample size for the BE decision via the FDA procedure for highly variable NTIDs (see the FDA’s dabigatran / rivaroxaban guidances).

Minor changes

• power.HVNTID() and power.NTIDFDA() now return the power (p(BE)) and the components for the scaled ABE criterion, the conventional ABE test and the test for the ratio s_wT/s_wR <= 2.5 if the argument details=TRUE (wish of Helmut Schütz).
• power.RSABE() now returns the power (p(BE)) and the components for the scaled ABE criterion, for the point estimate criterion and for the conventional ABE test alone if the argument details=TRUE. Analogous changes were made in power.scABEL(). See man-pages.

PowerTOST 1.2-9

On CRAN 2015-08-26.

Bug fixes

• power.TOST() with method="exact" reworked to give correct values in case alpha>0.5. OwensQOwen() adapted to deal with upper integration limit R==Inf.

Major changes

• New power calculation method introduced: Direct integration of the bivariate non-central t-distribution (pmvt() of package mvtnorm), also an exact calculation method but with somewhat lower precision and longer run-time. Contributed by Benjamin Lang.
• New function power.TOST.sim() to obtain the power via simulations of the TOST. Only intended for checking purposes.

PowerTOST 1.2-8

On CRAN 2015-07-10.

Minor changes

• Maintenance release with NAMESPACE adapted to import the necessary functions from base R installation (CRAN request).
• power.NTIDFDA() and sampleN.NTIDFDA() now have an design argument to choose between "2x2x4" (full replicate 4-period) and "2x2x3" (full replicate 3-period design).
• Some minor documentation improvements.

PowerTOST 1.2-7

On CRAN 2015-06-03.

Major changes

• Functions power.scABEL() and sampleN.scABEL() now allow the power and sample size calculations for scaled ABEL according to the (inofficial) regulatory settings of Brasilian ANVISA (argument regulator="ANVISA").
• Function pa.scABE() also allows regulator="ANVISA".
• New helper function scABEL for calculation of the (widened) ABE acceptance limits.
• Deprecated function power2.TOST() removed.

PowerTOST 1.2-6

On CRAN 2015-01-23.

Major changes

• Function power.TOST() now handles balanced as well as unbalanced studies. Function power2.TOST() is therefore deprecated and will be removed in later versions.

Minor changes

• Internal change in interface to the (hidden) 'raw' power functions (sem used in function calls instead of se, n, bk).
• BE_power_sample_size_excerpt.pdf in subdirectory /doc changed to reflect the internal changes.

PowerTOST 1.2-5

On CRAN 2015-01-07.

Bug fixes

• Bug in OwensQOwen() removed (debug code left over), THX to Helmut for discovering this.

Minor changes

• Function CVfromCI() and alias CI2CV() now handle unbalanced studies. Contributed by Benjamin Lang.
• Typos in BE_power_sample_size_excerpt.pdf (discovered by Ben) corrected.

PowerTOST 1.2-4

On CRAN 2014-12-19.

Bug fixes

• Bug in OwensT(h, a) for the case of a=-Inf removed. Thanks to Benjamin Lang for discovering that nasty bug.

Major changes

• Function pvalue.TOST() introduced to calculate the two p-values of the TOST procedure. Contributed by Benjamin Lang.

Minor changes

• Functions power.noninf(), exppower.TOST(), exppower.noninf() adapted to deal with unbalanced studies.

PowerTOST 1.2-3

On CRAN 2014-11-13.

Bug fixes

• Minimum sample size in sampleN.dp() introduced to avoid errors with small CV (<= 0.1) for the crossover design.

Major changes

• Functions power.dp() / sampleN.dp() cover "incomplete block designs".
• Liu’s 2x2x2 design with 2 repeated measurements in each period added (see ?known.designs under Notes).

Minor changes

• Partitition of n(total) to (sequence) groups reworked in most power functions if design is unbalanced.

PowerTOST 1.2-2

On CRAN 2014-10-06.

Minor changes

• Functions pa.XYZ() adapted so that they also work under R < 3.1.1 (request of Uwe Ligges of CRAN) although with minpower >= 0.5.

PowerTOST 1.2-1

On CRAN 2014-09-30.

Bug fixes

• Some minor bugs removed and spelling in man-pages corrected.

Minor changes

• Print method for class pwrA now calls plot().
• Power analysis in case of n=12 for the plan now drops n below 12 subjects.

PowerTOST 1.2-0

Build 2014-09-19, released to alpha/beta testers only.

Major changes

• Functions for power analysis of a sample size plan for ABE (pa.ABE()), scaled ABE (pa.sABE()) and scaled ABE for NTIDs (pa.NTIDFDA()) analyzing power for deviations from assumptions for the sample size estimation.
• Experimental functions for power calculations / sample size estimation for dose proportionality studies using the power model.

PowerTOST 1.1-13

On CRAN 2014-08-12.

Bug fixes

• Design constant bk(ni) for design="paired" corrected. THX to Helmut Schütz who detected this bug.

PowerTOST 1.1-12

On CRAN 2014-07-02.

Minor changes

• Improvements in documentation.
• Function power.TOST() now throws a warning if used with imbalanced designs (n not an even multiple of the number of sequences).
• Internal change of start value of sample size search in sampleN.TOST() to avoid failed searches if variability is high and theta0 is close to 1.

PowerTOST 1.1-11

On CRAN 2014-04-30.

Major changes

• Utility function added which calculates 1–2α confidence interval(s) given point est., CV and n using log-tansformed evaluation.
• Utility function added which calculates 1–2α Fieller confidence interval(s) given point est., CV (, CVb) and n for the ratio of untransformed means.

PowerTOST 1.1-10

On CRAN 2014-01-31.

Bug fixes

• Bug removed where noncentrality parameters in the power calculations became NaN (not a number).

Major changes

• The package is now pre-compiled to 'byte code' via the compiler package for speed reasons. F.i. OwensQOwen() gains a sixfold speed boost.
• Some bulk code changes to make the power calculations for extreme cases more bullet proof without computation time burden.
• OwensQ() now tries to return a value via nct-approximation if its value is due to numeric difficulties falsely equal zero. This approximation is up to 6 decimals correct as far as tested. OwensQ() issues a warning if the nct-approximation is used.

Minor changes

• Improvements in documentation (man-pages and *.pdf) to reflect the code changes.

PowerTOST 1.1-9

Build 2014-01-03, not released to the public.

Major changes

• OwensQ() now uses OwensQOwen() in case of high delta and/or high upper integration limit. Thus extreme cases can be handled properly where the former implementation via integrate() was prone to fail. Thanks to Jiři Hofmann and Helmut Schütz for pointing me to such extreme cases.

PowerTOST 1.1-8

On CRAN 2013-12-27.

Bug fixes

• Date typos in the history (NEWS) corrected from PowerTOST 1.1-00 on. THX to Julien Grassot.

Minor changes

• CVfromCI() now accepts either both CLs or one CL and the point estimate. Contributed by Helmut Schütz.
• power.RatioF() and sampleN.RatioF() now have an argument setseed=TRUE which avoids the dependence of the power from the state of the random number generator (due to the calculation method of pmvt() of package mvtnorm). Thanks to Benjamin Lang.

PowerTOST 1.1-7

On CRAN 2013-09-02.

Major changes

• design="2x2x3" (TRT|RTR) implemented in power.scABEL(), sampleN.scABEL() and in power.RSABE(), sampleN.RSABE().

Minor changes

• power.scABEL() now throws a warning if CV_wT ≠ CV_wR in the design "2x3x3" (partial replicate).
• Simulation details for the full replicate design slightly changed to obtain better numeric agreement of power to subject data sims.

PowerTOST 1.1-6

On CRAN 2013-06-21.

Bug fixes

• Fat bug corrected in sampleN.NTIDFDA() which lead to false sample size for cases where the test of equal variabilities of Test vs. Reference comes into effect.

PowerTOST 1.1-5

On CRAN 2013-06-17.

Bug fixes

• Flaw in sample size search corrected which does not indicate a failed search (n=NA) if started with a too high n. Thanks to Helmut Schütz.

Major changes

• Functions sampleN.scABEL(), sampleN.RSABE() and sampleN.NTIDFDA() return a data.frame with the input and the sample size result. The "Sample size" column contains the total sample size. The "nlast" column contains the last n value handled. Might be useful for restarting.

Minor changes

• Start values for sample size search in functions sampleN.scABEL(), sampleN.RSABE() reworked. Failed sample size searches are now more seldom observed.

PowerTOST 1.1-4

Build 2013-05-15, relased to alpha testers only.

Major changes

• Functions power.NTIDFDA() and sampleN.NTIDFDA() introduced to calculate power and sample size for the BE decision via the method of the FDA for narrow therapeutic index drugs (NTIDs, for details see the FDA’s warfarin guidance). Power and sample size are based on simulations.

PowerTOST 1.1-3

On CRAN 2013-05-03.

Bug fixes

• Flaw in implementing simulations of "2x3x3" design with different intra-subject variabilities in functions power.RSABE() and sampleN.RSABE() as well as in functions power.scABEL() and sampleN.scABEL() corrected.

Minor changes

• Methods and implementation details of the simulations for scaled ABE documented in a PDF file in the /doc subdirectory of the package.
• Simulation method for the EMA scaled ABEL changed to conform better with power values from simulations via subject data.
• Warning section in the help file of power.scABEL() introduced to reflect the fact that simulations via subject data and via the methods implemented in power.scABEL() gave empirical power values that are only approximately in agreement.

PowerTOST 1.1-2

On CRAN 2013-02-28.

Major changes

• Functions power.RSABE() and sampleN.RSABE() introduced to calculate power and sample size for the BE decision via linearized scaled ABE criterion as favored method of the FDA. Power and sample size are based on simulations.
  Default of nsims changed to 1E5 (suggested by Helmut Schütz).

Minor changes

• Argument setseed introduced in the scaled ABE functions to avoid different outcomes depending on the state of the (pseudo) random number generator. If setseed=TRUE a set.seed(123456) is issued prior to each call of the simulation functions.
• Documentation improved.

PowerTOST 1.1-0

On CRAN 2013-02-08.

Major changes

• Functions power.scABEL() and sampleN.scABEL() introduced to calculate power and sample size for the BE decision via scaled (widened) BE acceptance limits based on simulations. Thanks to Helmut Schütz on the BEBA Forum for power testing these functions.

PowerTOST 1.1-01

Not released, integrated in 1.1-00

Major changes

• Upper one-sided CL of the CV and therefore argument alpha2 removed from expsampleN.noninf() and expsampleN.TOST() because it lead to some confusion in users thinking this had to do with the algorithm via expected power.

Minor changes

• CI2CV() as alias to CVfromCI() introduced because myself always typed this name if aimed to calculate the CV from a given CI.
• Function CVCL() now returns a 2-element vector also if an one sided interval is requested.

PowerTOST 1.0-0

On CRAN 2012-10-26.

Bug fixes

• Bugfix in power.noninf() to get the correct power if theta0 is below margin (if margin <1) or theta0 is above margin (if margin >1). power.noninf() calculated up to now the power of an inferiority test. Thanks to Helmut Schütz.

Major changes

• New helper functions CV2mse() and mse2CV().
• New function CVCL() to calculate a confidence interval of a CV.

PowerTOST 0.9-11

On CRAN 2012-08-07.

Bug fixes

• In power.TOST(), power2.TOST() and power.noninf() to use the correct degrees of freedom depending on argument robust. robust=FALSE wrongly used the robust dfs. Thanks to Ben.

PowerTOST 0.9-10

On CRAN 2012-07-20.

Bug fixes

• In internal function .Q.integrand().
• In nmin - has to be a multiple of steps to assure balance in sequence groups.
  Again thanks to Helmut Schütz for detecting both.

PowerTOST 0.9-9

On CRAN 2012-07-18.

Bug fixes

• Workaround introduced to handle numeric problems in integrate() if CV<5.3E-6. Thanks to Helmut Schütz.

Minor changes

• Minimum sample size adapted to design used (f.i. n=2 if design="paired").

PowerTOST 0.9-8

On CRAN 2012-04-05 (Easter egg).

Major changes

• Functions added for 'expected' power and sample size calculations based on it for the non-inferiority test for sake of completeness.
• Functions CVpooled(), exppower.TOST() and expsampleN.TOST() now also implemented for logscale=FALSE, i.e., contain this argument in their calls.
• Function OwensQOwen() made public. This is an implementation of the algorithm given by Owen in the original paper (Biometrica 1965) via repeated integration by parts.
  This function is only for comparative purposes.
• Function OwensT() made public. It is needed internally in OwensQOwen() but may be useful for other purposes.

PowerTOST 0.9-6/7

On CRAN 2012-03-26.

Bug fixes

• PowerTOST 0.9-7 is a small bug fix of PowerTOST required by CRAN. It contains the old release number 0.9-6 in the package man-page.

Major changes

• Functions added 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' within a BE study must be evaluated.
  Hint: Evaluation of Fluctuation in the EMA MR NfG (1999) between modified release formulation and immediate release product.

PowerTOST 0.9-4

On CRAN 2012-03-05.

Bug fixes

• Little bug in sampleN.TOST() removed which causes extra doubled output of n and power if n=4. Thanks to Ben on the BEBA Forum.

PowerTOST 0.9-3

On CRAN 2012-02-13.

Bug fixes

• Bug in power.TOST() removed which prevented calculation of power according to method = "exact".

Minor changes

• Sample size tables for replicate design "2x2x3" in /data sub-directory added.
• Sample size tables for replicate design "2x4x4" in /data sub-directory added.
• Scripts in the /test sub-directory made public.

PowerTOST 0.9-2

On CRAN 2011-12-24.

Major changes

• Function power2.TOST() added to allow power calculations for studies with unbalanced (sequence) groups.
• Argument exact replaced by method in power.TOST(), sampleN.TOST(). See help for these functions.
• Attention! The sample size for the parallel group design is now the total sample size (to be consistent across all functions).

Minor changes

• Sample size tables added for the "2x2" crossover and for the "parallel" group design to alleviate validation/qualification of the package.
  See data(package="PowerTOST").
• Scripts added in the /test sub-directory that create the sample size tables from the data section.
• Updated BE_power_sample_size_excerpt.pdf in the /doc sub-directory.

PowerTOST 0.9-0

On CRAN 2011-12-15.

Major changes

• Paired means design introduced.
• 'robust' argument added to nearly all functions.
  With robust=TRUE the degrees of freedom for the so-called robust evaluation (df2 in known.designs() output) will be used.
  This may be helpful if planning is done for higher order designs evaluated via mixed model or via intra-subject contrasts (aka Senn’s basic estimator).
• Due to the necessary NAMESPACE from R1.4.0 on the internal functions (names starting with .) are no longer exported.

PowerTOST 0.8-7

On CRAN 2011-10-20.

Bug fixes

• Problem with slash in \name field of manual resolved (requested by Brian Ripley).

PowerTOST 0.8-6

On CRAN 2011-05-18.

Bug fixes

• Bug removed which gave incorrect exact power values in case of alpha>=0.5 (very unusual setting). Thanks again to Craig Zupke.
  Cross checked results of power at equivalence margins against SAS Proc Power.

PowerTOST 0.8-5

On CRAN 2011-05-16.

Bug fixes

• Code in Owen’s Q adapted to account for large delta or large b leading to integrand function almost zero over the whole range which then gave an error in integrate(). Thanks to Craig Zupke.

PowerTOST 0.8-4

On CRAN 2011-03-11.

Minor changes

• Number of maximal steps in sample size search in the sample size functions, formerly hard coded as 50, made accessible to users via argument imax. Needs to be adapted only in rare extreme cases.
• Start value for sample size search improved around theta0=1 (logscale) or theta0=0 (untransformed).

PowerTOST 0.8-3

On CRAN 2011-01-18.

Bug fixes

• In known.designs().

PowerTOST 0.8-2

On CRAN 2011-01-10.

Bug fixes

• Error in df for "3x3" and "4x4" crossover designs removed.

Major changes

• Function for pooling CVs of different studies made public. See ?CVpooled.

PowerTOST 0.8-1

On CRAN 2010-11-25.

Major changes

• Helper function CVfromCI() added to estimate the CV from a confidence interval. Useful if no CV but the CI was given in literature.

PowerTOST 0.7-3

On CRAN 2010-11-25.

Major changes

• Input argument diff removed from sampleN.TOST(), expsampleN.TOST(), power.TOST(), and exppower.TOST().

Minor changes

• Documentation improved.

PowerTOST 0.7-2

On CRAN 2010-08-27.

• Little bug causing warnings in case of the "2x2" alias "2x2x2" design corrected.

PowerTOST 0.7-1

On CRAN 2010-08-12.

Major changes

• Functions added 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).
  AFAIK, until now only implemented in the commercial nQuery.

Minor changes

• The argument diff (Null ratio / Null diff.) is now named theta0 since it was annoying for users to call it diff in case of ratios (logscale=TRUE). The parameter diff is still supported but will be removed in the next release. Therefore a warning is thrown if diff is used.

PowerTOST 0.6-2

On CRAN 2010-07-21.

Major changes

• Previously internal hidden functions .CV2se() and .se2CV() made public.

Minor changes

• Some internal code consolidation
• Minor enhancements in help pages, more examples.
• Short documentation of used statistical apparatus BE_power_sample_size_excerpt.pdf for classical power / sample size in directory /doc added.

PowerTOST 0.5-1

On CRAN 2010-05-07, first public release.