Bioequivalence and Bioavailability Forum • partial AUCs in SD

partial AUCs in SD [NCA / SHAM]

posted by Vishal S – India, 2021-08-02 15:41 (1370 d 19:45 ago) – Posting: # 22495
Views: 4,191

❝ ❝ 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?

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 SDVishal S 2021-08-02 13:41
      - partial AUCs in SD Helmut 2021-08-02 14:05
    - Already AUClast: ? ≠ ? Helmut 2021-08-02 13:56