Regarding Dosing Regimen in BE study of Paracetamol SR 665mg [Design Issues]
Dear Sir,
I am planing to conduct BE study of Paracetamol SR 665mg tablets compare with Panadol Osteo 665mg extended release tablets (Australia). My query is that; how many tablets to be administered in single dose BE study and multiple dose BE study, please suggest. As per the PI of Panadol Osteo the dosing regimen is 2 tablets thrice daily for patients in the treatment of osteoarthritis.
This study is plan for Australia submission.
Thanks & Regards,
Om Prakash
Edit: Category changed; see also this post #1. [Helmut]
I am planing to conduct BE study of Paracetamol SR 665mg tablets compare with Panadol Osteo 665mg extended release tablets (Australia). My query is that; how many tablets to be administered in single dose BE study and multiple dose BE study, please suggest. As per the PI of Panadol Osteo the dosing regimen is 2 tablets thrice daily for patients in the treatment of osteoarthritis.
This study is plan for Australia submission.
Thanks & Regards,
Om Prakash
Edit: Category changed; see also this post #1. [Helmut]
Complete thread:
- Regarding Dosing Regimen in BE study of Paracetamol SR 665mgomprakash 2016-06-08 09:54 [Design Issues]