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Registerpartial AUCs in SD [NCA / SHAM]
posted by Helmut 
– Vienna, Austria, 2021-08-02 14:05 (52 d 20:33 ago) – Posting: # 22497
Views: 1,012
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.
» 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.
—
Dif-tor heh smusma 🖖
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
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Dif-tor heh smusma 🖖
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- partial AUC Vishal S 2021-08-02 09:20 [NCA / SHAM]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 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
- partial AUCs in SD Vishal S 2021-08-02 13:41
- partial AUCs in SD Relaxation 2021-08-02 13:36
- partial AUCs in SD Helmut 2021-08-02 12:53
Ing. Helmut Schütz