Bioequivalence and Bioavailability Forum

Hello all,

This is my 1st post here and excited to learn/share science.

I just want to share and ask your suggestions.

My study - I am carrying out Virtual BE studies for a SR-formulations and comparing its PK endpoints (Cmax, AUC).

Doubt - I am confused or doubting my manually chose PK sampling time points.

Drug X - Tmax - 8.40hr

Therefore, I chose 12 time points (aligns with US regulatory guideline) - 1, 3, 5, 6, 7, 7.5, 8, 8.5, 9, 10, 16, and 24 hrs which covers that absorption, distribution and elimination phase of the compound.


Any suggestions here to capture the PK profile the drug much better?

Thanks,
Titus