Bioequivalence and Bioavailability Forum • R, packages (e.g. PowerTOST) and regulatory issues (e.g.FDA)

R, packages (e.g. PowerTOST) and regulatory issues (e.g.FDA) [🇷 for BE/BA]

posted by Jérôme Martin – France, 2013-03-19 18:42 (4379 d 13:16 ago) – Posting: # 10238
Views: 14,056
(edited on 2013-03-20 15:42)

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 regarding regulatory issues (FDA mainly and/or EMA) and I’m asking if using R and dedicated package (especially PowerTOST) has already be done and accepted at this stage (clinical ANDA)? If it’s routinely done by other statisticians? If R and this package are known from regulators?

In any cases, did you have advice how to manage those regulatory issues (special letter to regulators? presentation of software or data?...) for a clinical ANDA BE trial with R and packages such as PowerTOST?

I’m aware that FDA made recent clear statement about statistical software, but it’s to have your opinions and feedback.

Complete thread:

R, packages (e.g. PowerTOST) and regulatory issues (e.g.FDA)Jérôme Martin 2013-03-19 17:42 [🇷 for BE/BA]
- 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
  - 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