Global Cmax (MD and SD) [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2020-05-11 19:51 (1497 d 11:20 ago) – Posting: # 21421
Views: 3,530

Hi Nathalie,

❝ 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.

I see. Of course, scientifically this design is than better than two separate studies because you could assess whether you have linear PK (MD AUC0–τ ≈ SD AUC0–∞; evaluated as a paired design). However, only “nice to know”.

❝ 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?

Sure. BTW, that’s the same approach I used in my studies for the EMA.
One minor warning. Since the FDA in the NDA/IND guidance specifically recommends two studies, you risk a Refuse-to-Receive. Given, that’s for ANDAs but a controlled correspondence with the OGD will not hurt.

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