Food effect in FIM [General Sta­tis­tics]

posted by Ohlbe – France, 2019-02-08 21:58  – Posting: # 19894
Views: 547

Dear Babe_Ruth and ElMaestro,

» » Yikes. Do you mean single ascending doses, mutiple ascending doses? That would likely make this a first in man, potentially?? I am not sure I would like to offer opinions on those. Is the API very well known??
»
» Yes, that's what I meant with SAD and MAD. Yes, first in human.

OK, this explains your study design. See EMA's FIM guideline, section 8.2.2 page 15:
Other single dose parts (e.g. food interaction) could be conducted in parallel to the SAD part provided the dose chosen and the expected exposure are equal to or lower than that which was reached in a concluded preceding SAD cohort where all relevant data has been reviewed and no dose escalation stopping criteria were met.


BTW Helmut: the guidance page still points to the old 2007 version of the guideline, not the 2018 version.


Edit: THX, added. [Helmut]

Regards
Ohlbe

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