Bioequivalence and Bioavailability Forum • BE XR OD vs IR BID

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

posted by jag009 – NJ, 2020-05-11 08:29 (1668 d 19:12 ago) – Posting: # 21417
Views: 4,256

❝ I would like to have the help of the forum participants on a tricky question, ie which IR Cmax should be considered to assess the potential bioequivalence between an IR formulation administered BID and an XR formulation administered OD on day 1 and at steady-state. This is for a submission to FDA.

Not sure if the following will answer your Q exactly and whether it still exists on FDA website (or they blacked out the results):
Look for Ultram ER at Drugs@FDA.
Similar approach (Don't ask how I know :))

J

Complete thread:

BE XR OD vs IR BID - which Cmax for IR? Nathalie T 2020-05-08 16:40 [Regulatives / Guidelines]
- 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