Bioequivalence and Bioavailability Forum

Naproxen ER FDA guidance [Regulatives / Guidelines]

posted by jag009  – NJ, 2014-04-15 17:36 (4456 d 10:27 ago) – Posting: # 12842
Views: 4,523

Hi Helmut and Mac,

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.

John

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Edit: This is your post #500. Congratulations! [Helmut]

Complete thread:

• Naproxen ER FDA guidance lechia 2014-04-14 22:57 
  • Naproxen ER FDA guidance Helmut 2014-04-15 13:09
    • Naproxen ER FDA guidancejag009 2014-04-15 15:36
    • Naproxen ER FDA guidance lechia 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