Bioequivalence and Bioavailability Forum • BE study design issue

BE study design issue [Design Issues]

posted by Dr_Dan – Germany, 2019-12-18 16:04 (1762 d 15:02 ago) – Posting: # 20992
Views: 3,951

Hi John
if the recommended dosage regimen of the IR as per product monograph IR is to be given every 4 hrs then this means that higher doses have either a safety issue or the dose/effect relationship is in disfavor of higher doses. In this case AUC alone does not matter. Consequently, a regulatory body will reject the study
Hope this helps
KR
Dr_Dan

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Kind regards and have a nice day
Dr_Dan

Complete thread:

BE study design issue jag009 2019-12-13 23:26 [Design Issues]
- 1×2 ≠ 2×1 Helmut 2019-12-14 00:42
  - 1×2 ≠ 2×1 jag009 2019-12-15 19:39
    - 1×2 ≠ 2×1 ElMaestro 2019-12-15 22:02
      - x ◦ y = y ◦ x? Helmut 2019-12-16 11:00
- BE study design issueDr_Dan 2019-12-18 15:04
  - ER vs. IR Helmut 2019-12-18 15:33
    - ER vs. IR Dr_Dan 2019-12-19 09:01