Bioequivalence and Bioavailability Forum

Dear all!

❝ ❝ 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.

Yep. When it comes to PowerTOST the scripts in the \tests\ folder make validation an easy task.

❝ 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.

Yessir. Same with Phoenix/WinNonlin, where the ‘Partial Tests’ are expected to agree with SAS’ Type III LSMs in most of cases (whereas the ‘Sequential Tests’ ≡ SAS’ Type I). BTW, the FDA uses not only SAS and R, but also MATLAB and Phoenix themselves.