Difference between actual and published PK parameters [Study As­sess­ment]

posted by ElMaestro  – Denmark, 2022-02-14 23:09 (101 d 16:24 ago) – Posting: # 22782
Views: 921

Hi Loky do,

I don't think I can disagree with anything dhsah and Helmut wrote, but in addition to their comment I'd like to point out that this is a drug metabolised by CYP2D6 and 3A4. You might indeed see some differences across races. If the study you are comparing with was done in a population a little different from yours then chances are that you'd see different elimination constants etc.
Check the SPC. Don't be fooled by the innocent remark about race differences. Jump instead to the remark about polymorphism. If you are not certain that the t½ reported came from a population similar to yours then I'd conveniently throw the race factor on the table as a likely potential reason for PK-differences.

Pass or fail!
ElMaestro

Complete thread:

UA Flag
Activity
 Admin contact
22,108 posts in 4,630 threads, 1,567 registered users;
online 4 (0 registered, 4 guests [including 3 identified bots]).
Forum time: Friday 16:34 CEST (Europe/Vienna)

We absolutely must leave room for doubt
or there is no progress and no learning.
There is no learning without having to pose a question.
And a question requires doubt.
People search for certainty.
But there is no certainty.    Richard Feynman

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5