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!

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