Bioequivalence and Bioavailability Forum

Hi Angus,

❝ […] I can see why if you work in the generic area that you need structure to be efficient.

Not only generics… I only try to be efficient in order to have spare time for the more interesting stuff.

❝ Recently I got some actual times from clinical data: the information was transcribed over from the case report forms and then put into Excel. I had to write Excel routines to subtract times to get the actual times at each time point. This was a Phase 2 study so the adherence to stipulated times was not good.

Oh yes. Nasty in Excel. I implemented these routines in PHX – not much nicer. Life would be much easier if software developers (and guys setting up CRFs and clinical data management systems as well) would implement ISO 8601 completely. Both Excel and Phoenix use a “crippled” version. Did you ever transfer an Excel-sheet containing timestamps from a PC to a Mac? Whereas on Windows the timebase is 1900-01-01 00:00:00, the default on a Mac it is 1904-01-01 00:00:00. The difference is four years, but 366+365+365+365 days. 1900 was a leap year with a Feb. 29^th… Better to change the timebase before. For a funny story see the end of this post.

❝ Yet at the end of the day the data analysis showed no significant differences between the AUC parameters. They were almost the same so was the CV(%).

Yep, it rarely (if ever) matters. I have uses scheduled times for almost two decades. As long as you are consistent it should be OK. But at least the EMA and WHO clearly stated that they prefer actual times – which makes sense.

P.S.: I just tested the latest Pre-Release of PHX1.4. The CVs for higher-order Xovers are not implemented yet.