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, 2013-03-27 12:59 (4407 d 22:52 ago) – Posting: # 10293
Views: 11,895

Thanks for all the responses adn links! It will help me to prepare internal meetings.

To follow the discussion, I'm wondering what are the views about R from local agency such as ANSM in France for example. In other words, FDA made statment about using R, but what are the opinions of local agencies? For example when companies uses strategy of filling a clinical study in early phase in some country and then move to FDA/EMA, you have to write a SAP to a local agency, and what are your experience with filing an R based SAP in these cases?

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