Tmax problems [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2023-10-12 08:55 (248 d 20:58 ago) – Posting: # 23751
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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 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.

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