Bioequivalence and Bioavailability Forum

partial AUCs in SD [NCA / SHAM]

posted by Helmut  – Vienna, Austria, 2021-08-02 16:05 (546 d 16:33 ago) – Posting: # 22497
Views: 1,697

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.
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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Helmut Schütz


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Complete thread:

• partial AUC Vishal S 2021-08-02 09:20 [NCA / SHAM] 
  • partial AUCs in SD Helmut 2021-08-02 12:53
    • partial AUCs in SD Relaxation 2021-08-02 13:36
      • partial AUCs in SD Vishal S 2021-08-02 13:41
        • partial AUCs in SDHelmut 2021-08-02 14:05
      • Already AUClast: ? ≠ ? Helmut 2021-08-02 13:56