Bioequivalence and Bioavailability Forum

FDA: Draft guidance MPH suspension [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2014-12-31 14:40 (4199 d 11:34 ago) – Posting: # 14206
Views: 5,367

Dear all,

and the methylphenidate-story continues. On Dec 18 the FDA published a new draft for MPH extended release suspension. In line with the ER tablet guidance, three partial AUCs instead of only two in the Sep 2012 draft (see also here about cut-points).
But: 2×2 crossovers (no S × F interaction assessed in fully replicated studies).
I don’t understand these guys.

Submit your comments to regulations.gov until Feb 23, 2015.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

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Complete thread:

FDA: Draft guidance MPH suspensionHelmut 2014-12-31 13:40
- FDA: Draft guidance MPH suspension AngusMcLean 2015-01-01 21:25
  - Replicate instead of Xover Helmut 2015-01-01 23:07
    - Replicate instead of Xover AngusMcLean 2015-01-02 00:22
      - Replicate instead of Xover Helmut 2015-01-02 01:11

FDA: Draft guid­ance MPH suspension [Regulatives / Guidelines]

Complete thread:

FDA: Draft guidance MPH suspension [Regulatives / Guidelines]