Bioequivalence and Bioavailability Forum • BE XR OD vs IR BID - which Cmax for IR on day 1?

BE XR OD vs IR BID - which Cmax for IR on day 1? [Regulatives / Guidelines]

posted by Nathalie T – Belgium, 2020-05-18 18:23 (2229 d 13:42 ago) – Posting: # 21452
Views: 5,575

Hi,

❝ I don't recall but I did a single dose study there (sorry I didn't read your post fully. You mean a single-dose to steady state study (one study)?)

It is indeed SD + steady-state in one study, hence the question is for the Cmax on day 1 and the Cmax at steady-state.

Regards

Nathalie

Complete thread:

BE XR OD vs IR BID - which Cmax for IR? Nathalie T 2020-05-08 16:40
- FDA ER vs. IR: Global Cmax Helmut 2020-05-09 11:54
  - FDA ER vs. IR: Global Cmax for Day 1 too? Nathalie T 2020-05-11 15:59
    - Global Cmax (MD and SD) Helmut 2020-05-11 17:51
- BE XR OD vs IR BID - which Cmax for IR? jag009 2020-05-11 06:29
  - BE XR OD vs IR BID - which Cmax for IR on day 1? Nathalie T 2020-05-11 16:02
    - BE XR OD vs IR BID - which Cmax for IR on day 1? jag009 2020-05-12 21:16
      - BE XR OD vs IR BID - which Cmax for IR on day 1?Nathalie T 2020-05-18 16:23

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