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RegisterR, packages (e.g. PowerTOST) and regulatory issues (e.g.FDA) [🇷 for BE/BA]
posted by yjlee168 
– Kaohsiung, Taiwan, 2013-03-20 23:01 (4414 d 16:04 ago) – Posting: # 10251
Views: 12,244
Dear all,
The R Foundation for Statistical Computing has an official document (Dec. 28, 2012) about "R: Regulatory Compliance and Validation Issues A Guidance Document for the Use of R in Regulated Clinical Trial Environments". Looks like this document is updated from time to time. Also, Soukup of FDA had slides about "Using R: Perspectives of a FDA Statistical RevieweR". Hope these two documents can help the discussion. The content of Soukup's slide may need to be updated.
PowerTOST is a great tool in sample size and power estimation, especially in RSABE/scABE. I can bet that Detlew Labes must spend a lot of time and efforts to develop it and improve it. I used to download its tar file (containing all source codes; welcome to the open source world!) from CRAN and study its coding skills. I do learn a lots from it.
Thanks for compliments. Hope the next release will get much better.
The R Foundation for Statistical Computing has an official document (Dec. 28, 2012) about "R: Regulatory Compliance and Validation Issues A Guidance Document for the Use of R in Regulated Clinical Trial Environments". Looks like this document is updated from time to time. Also, Soukup of FDA had slides about "Using R: Perspectives of a FDA Statistical RevieweR". Hope these two documents can help the discussion. The content of Soukup's slide may need to be updated.
❝ ❝ 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)...
PowerTOST is a great tool in sample size and power estimation, especially in RSABE/scABE. I can bet that Detlew Labes must spend a lot of time and efforts to develop it and improve it. I used to download its tar file (containing all source codes; welcome to the open source world!) from CRAN and study its coding skills. I do learn a lots from it.
❝ ...
❝ For evaluation of BE in R you need e.g. Yung-Jin Lee's excellent BEAR or ...
Thanks for compliments. Hope the next release will get much better.
—
All the best,
-- Yung-jin Lee
bear v2.9.2:- created by Hsin-ya Lee & Yung-jin Lee
Kaohsiung, Taiwan https://www.pkpd168.com/bear
Download link (updated) -> here
All the best,
-- Yung-jin Lee
bear v2.9.2:- created by Hsin-ya Lee & Yung-jin Lee
Kaohsiung, Taiwan https://www.pkpd168.com/bear
Download link (updated) -> here
Complete thread:
- R, packages (e.g. PowerTOST) and regulatory issues (e.g.FDA) Jérôme Martin 2013-03-19 17:42 [🇷 for BE/BA]
![[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