Bioequivalence and Bioavailability Forum

Dear DLabes!

❝ But non-parametrics is not in the scope of standard statistical education or standard statistical text books.

1. That’s a pity!
   
2. … but in the context of BE extensively covered in ‘specialized’ textbooks:
   Chow & Liu (2000), Senn (2002), Jones & Kenward (2003), Patterson & Jones (2006), Hauschke et al. (2007) – for references see this post.

❝ Moreover there is not a lot of software out there to deal with.

True. At least for a 2×2 design EquivTestPK would help, but even the freeware R is an option (references).

❝ In SAS for instance, which I have to deal with, no standard method is implemented for obtaining CIs. You have to program methods from the scratch. Not an easy task.

OK, but you may opt for Cytel’s StatXact PROCs for SAS. Caution: The correct Hodges-Lehmann CI is not available from the pull-down menu but must be obtained from the command line according to Senn (2002 p.121). I’ve had a lot of conversations with Cytel’s support in the past (and finally gave up with v6.1 of 2003 – maybe the issue is resolved in the current version 8).

❝ ❝ One possibility comes into my mind: Performing a parametric evaluation of the replicate design, but not on the untransformed raw data of t_max, but on the ranks within each period.

❝ Ok, that may help for p values but not for confidence intervals, at least not in SAS.

OK, since I’ve got no SAS license, this is beyond my horizon.
Thanks a lot for your references!