Bioequivalence and Bioavailability Forum • Naproxen ER FDA guidance

Naproxen ER FDA guidance [Regulatives / Guidelines]

posted by lechia – C of U, 2014-04-15 18:10 (4445 d 14:03 ago) – Posting: # 12843
Views: 4,469

Thank you for your input, Helmut and John.

❝ I don’t think so, since the FDA specifically asks for t_max and not for partial AUCs. The truncation time-points (early onset and prolonged action) for other ER drugs (methylphendiate and zolpidem) are based on pharmacodynamics (not the reference’s median t_max used for early exposure). I’m not aware whether such data exists for ER naproxen.

No, you're right. In fact, according to the label, these ER tablets are supposed to work over 24h. They are made up of an immediate acting (30%) portion and a delayed release portion that's supposed to be released over a whole day.

❝ Probably use the same approach as in assessing lagtime similarity between T and R. We did that before for a product with specific lagtime, Covera HS (for FDA). Yes nonparametric test will do (Wilcoxon signed rank test was what we submitted with and no issue came back.

What significance level did you use, John? Given that there is no guidance on this, it seems like anything reasonable (as long as it's in the protocol prior to the start) would be fine?!? z_0.05,N?

Thank you for your help.

Complete thread:

Naproxen ER FDA guidance lechia 2014-04-14 22:57 [Regulatives / Guidelines]
- Naproxen ER FDA guidance Helmut 2014-04-15 13:09
  - Naproxen ER FDA guidance jag009 2014-04-15 15:36
  - Naproxen ER FDA guidancelechia 2014-04-15 16:10
    - Naproxen ER FDA guidance lechia 2014-04-24 16:49
      - Naproxen ER FDA guidance sunny 2014-04-25 02:43
  - Naproxen ER FDA guidance sunny 2014-04-17 00:07