Bioequivalence and Bioavailability Forum

Hello Jag,

❝ One more question, what if the last two points of the elimination phase is going in the positive direction and the points before them (lets say 3 points, yes after Cmax) are declining?

This happens actually quite frequently in inhalation and nasal BE studies.
It really, really stinks and is PP implausible when the last value is 3x the previous one and the preceding 6 values have been dropping nicely etc. Plausibility (or foul smell for that matter) is, however, not always a good reason to ignore anything. Therefore more meat to the bone is necessary.

When I see it I usually tell my clients to have a look at the bioanalytical validation and possibly consider an audit. Silly clients will flat out refuse auditing* while wiser clients will do it. Once the dust settles things sometimes make more sense.

Best regards,
EM.

* typical excuses:

1. "We have contracted with this lab previously and we have no reason to suspect any deviations." (But if you further ask if they have audited the supplier the answer is often no. Absence of evidence vs evidence of absence....).
   
2. "The Virgin Island's Drug Agency (or whatever) inspected the bioanalytical lab in 1957 so we don't need to audit".
   
3. "Their QC-head's son was on the same soccer team as my son in pre-school. You should've seen them when they hammered Snottsville 3-0 back in 1982. Definitely no worry here."