Bioequivalence and Bioavailability Forum

Hi Simon,

I never have seen any difference between SAS and PHX/WNL – if the ‘right’ coding was used. One exception are parallel designs, where PHX/WNL assumes equal variances (Linda posted a workaround on the Extranet; see also this thread). Let’s see what v6.4 will do (any news about the release date?)…

Agencies want to have the CI in % rounded to two decimals. PHX/WNL’s core-output (which many people copy/paste to their reports) might state “Failed to show bioequivalence…” – even if the rounded CI would pass – because the software compares the CLs to the acceptance range in full precision. Might be confusing. I prefer to set up a series of transformations which also the assess­ment based on rounded results and construct a table.

❝ PS On the more general subject topic I've always used the maximum precision supplied (sure if full precision concs are supplied, some of it maybe 'random' numbers in the decimals but that too should 'round out') and rounded only at the end to minimise compounding of rounding errors.

True, that “noise” means out. But: Sometimes regulators don’t have access to the raw data and recalculate a study based on what is given in the report (limited precision). In the worst case results differ – questions arising,