FDA ER vs. IR: Global Cmax for Day 1 too? [Regulatives / Guidelines]

posted by Nathalie T – Belgium, 2020-05-11 15:59 (199 d 12:49 ago) – Posting: # 21419
Views: 1,688

Hi Helmut,

Thank you for your very useful answer.

» What do you mean by “day 1”? Do you want to sample full profiles in the multiple dose study both after the first dose and in steady state? That’s not required. The guidance recommends two studies: SD and MD. If you want to collapse the SD and MD studies into one, you may drain the subjects.

Indeed we are combining SD and MD studies into one, and we are going to collect full profiles on both days, and given the bioanalytical method, the volume we take is OK for the subjects.

So I have the same question for the concentrations on day 1. The IR is administered BID to be in conformittee with the previous cited FDA guideline. In my opinion the least common interval needs to be considered as a whole, here 24h, and the highest Cmax over this day 1 interval should be taken as the reference for the IR. And this is specific to the FDA.

Do you agree with that?

Edit: Standard quotes restored; see also this post #8[Helmut]

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