Tmax problems [Regulatives / Guidelines]
❝ 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 tmax 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!
The quality of responses received is directly proportional to the quality of the question asked. 🚮
- Tmax 90% confidence interval durga09 2023-09-08 10:21 [Regulatives / Guidelines]