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, 2013-03-20 11:32 (4835 d 02:01 ago) – Posting: # 10243
Views: 14,171
(edited on 2013-03-20 15:43)

Thanks to Ohlbe and El Maestro for their quick responses!

❝ 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.

I will certainly have a closer look to this package that I have discovered in this forum. But we have also WinNonlin Phoenix 1.3 at our compagny, so we plan to use it for BE outcome analysis. I will be able to do some hands-on comparisons with my own dataset.

❝ Doesn't the FDA systematically repeat the PK and stats calculations in ANDA BE studies ? If this is indeed the case, there is no reason they should raise any difficulty as long as they manage to reproduce your results.

This question is very interesting in the path of submiting an ANDA to the FDA, because it could put less pressure on software validation for this project?

Complete thread:

R, packages (e.g. PowerTOST) and regulatory issues (e.g.FDA) Jérôme Martin 2013-03-19 17:42
- 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