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RegisterR, packages (e.g. PowerTOST) and regulatory issues (e.g.FDA) [🇷 for BE/BA]
Hello Jérôme,
Power is usually the applicant's problem so I woudln't expect FDA to reject any dossier just because power has been calculated with a package that the FDA finds dubious. This is of course not to say that the powerTOST package is dubious; in fact this package is anything but.
Unless the package you use may calculate sample size so wrongly that a study is futile (unethical) there should not be too much trouble.
For evaluation of BE in R you need e.g. Yung-Jin Lee's excellent BEAR or some codelines of your own making and then the issue becomes more important. On basis of FDA's message I would say you can certainly validate an R script and use that.
❝ I’m preparing a clinical ANDA BE study for the company I work with and for that purpose I’m using R and the package PowerTOST (I’m computing power and sample size and also I use CVfromCI and CVpooled). I plan to perform both the statistical analysis plan (SAP) and the data analysis.
❝ I’m aware that FDA made recent clear statement about statistical software, but it’s to have your opinions and feedback.
Power is usually the applicant's problem so I woudln't expect FDA to reject any dossier just because power has been calculated with a package that the FDA finds dubious. This is of course not to say that the powerTOST package is dubious; in fact this package is anything but.
Unless the package you use may calculate sample size so wrongly that a study is futile (unethical) there should not be too much trouble.
For evaluation of BE in R you need e.g. Yung-Jin Lee's excellent BEAR or some codelines of your own making and then the issue becomes more important. On basis of FDA's message I would say you can certainly validate an R script and use that.
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- R, packages (e.g. PowerTOST) and regulatory issues (e.g.FDA) Jérôme Martin 2013-03-19 17:42
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- R, packages (e.g. PowerTOST) and regulatory issues (e.g.FDA)ElMaestro 2013-03-20 08:11
- R, packages (e.g. PowerTOST) and regulatory issues (e.g.FDA) Ohlbe 2013-03-20 10:18
- R, packages (e.g. PowerTOST) and regulatory issues (e.g.FDA) Jérôme Martin 2013-03-20 10:32
- FDA recalculation ElMaestro 2013-03-20 11:41
- validation Helmut 2013-03-20 15:06
- FDA recalculation ElMaestro 2013-03-20 11:41
- R, packages (e.g. PowerTOST) and regulatory issues (e.g.FDA) Jérôme Martin 2013-03-20 10:32
- R, packages (e.g. PowerTOST) and regulatory issues (e.g.FDA) yjlee168 2013-03-20 22:01
- R, packages (e.g. PowerTOST) and regulatory issues (e.g.FDA) Jérôme Martin 2013-03-27 11:59
- PowerTOST and BfArM Helmut 2013-03-27 14:23
- R, packages (e.g. PowerTOST) and regulatory issues (e.g.FDA) Jérôme Martin 2013-03-27 11:59
- R, packages (e.g. PowerTOST) and regulatory issues (e.g.FDA) Ohlbe 2013-03-20 10:18
- R, packages (e.g. PowerTOST) and regulatory issues (e.g.FDA)ElMaestro 2013-03-20 08:11
Ing. Helmut Schütz