Bioequivalence and Bioavailability Forum • Tmax problems

Tmax problems [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2023-10-12 08:55 (574 d 20:29 ago) – Posting: # 23751
Views: 3,693

Hi Durga,

❝ But as per guideline Tmax 90% CI should me 0.80 to 1.25 by this point does the study "pass" or "fail"

See this presentation as a starter. I guess you are referring the EMA’s product specific guidances on ibuprofen, paracetamol, and tadalafil.
Adding to what Mittyri wrote, perhaps this article helps.

Jiří Hofmann gave a presentation about t_max and partial AUCs at this year’s BioBridges conference (Prague, 21/22 September). It’s not online yet. Check the Archive till the 2023 link will appear.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

Tmax 90% confidence interval durga09 2023-09-08 10:21 [Regulatives / Guidelines]
- Tmax 90% confidence interval Achievwin 2023-09-09 12:44
  - link to the post of BEBAC golden collection mittyri 2023-09-10 19:55
    - link to the post of BEBAC golden collection durga09 2023-10-10 10:43
      - CI for difference in Tmax mittyri 2023-10-11 12:55
      - Tmax problemsHelmut 2023-10-12 06:55