partial AUCs in SD [NCA / SHAM]

posted by Helmut Homepage – Vienna, Austria, 2021-08-02 16:05 (941 d 07:48 ago) – Posting: # 22497
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Hi Vishal,

❝ as per your suggestion the partial AUCs will be AUC(0-12 hrs) & AUC12-24 hrs (Considering dosing interval of 24 hrs)


Yep. See my reply to Relaxation’s post.

❝ 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?


I’m not an assessor. :-D
If you have no missings, a sufficient LLOQ (all late concentrations measurable), and if the assessor is a ‘tick-the-box type’ (since \(\small{_\textrm{partial}AUC_{\textrm{cut off}-t_\textrm{last}}}\) is stated in the GL), all is good.
However, from a PK perspective (‼) it doesn’t make sense.

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