Steady state BE study dosing [Design Issues]

posted by dshah  – India/United Kingdom, 2024-01-22 11:09 (182 d 15:30 ago) – Posting: # 23837
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Hi NK!

❝ Kindly clarify, whether 2nd and 3rd dose on day 5 need to be administered or not? and sampling should be continued for 24 hours?


So you are asking for protocol preparation consideration. The study is in healthy volunteers- so I believe that AUC0-t/AUC0-inf>=0.8 also needs to be followed, so consider sampling accordingly.

Regards,
Divyen

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