Bioequivalence and Bioavailability Forum • FDA recalculation

FDA recalculation [🇷 for BE/BA]

posted by ElMaestro – Denmark, 2013-03-20 12:41 (4414 d 23:13 ago) – Posting: # 10245
Views: 12,115

Hi Jérôme,

❝ 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?

WHile it is true that FDA routinely recalculate trial outcomes I don't think this in itself relaxes any validation requirements.

Also note that for some re-calculations, if done in SAS, it may not be possible to verify exactly the results from R. The best case I can think of is mixed models with imbalance where the SAS Satterthwaite option for denominator DF's cannot be reproduced in R. There is simply no option for that at present if I remember correctly.

—
Pass or fail!
ElMaestro

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 recalculationElMaestro 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