partial AUCs in SD [NCA / SHAM]

posted by Vishal S – India, 2021-08-02 15:41 (487 d 09:15 ago) – Posting: # 22495
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❝ ❝ 5. \(\small{_\textrm{partial}AUC_{\textrm{cut off}-{\tau}}}\)

❝ This one I think should be: \(\small{_\textrm{partial}AUC_{\textrm{cut off}-t_\textrm{last}}}\)?

Hii Helmut

Thank you for above information
as per your suggestion the partial AUCs will be AUC(0-12 hrs) & AUC12-24 hrs (Considering dosing interval of 24 hrs)
what happen if we select partial AUCs ie AUC(0-12 hrs) & AUC12-72 hrs (Considering last sample collection time point ie 72 hrs) & prove the bioequivalence is this accepted by regulatory?

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