Regarding Dosing Regimen in BE study of Paracetamol SR 665mg [Design Issues]

posted by omprakash – India, 2016-06-08 11:54 (3171 d 20:42 ago) – Posting: # 16415
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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]

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