Bioequivalence and Bioavailability Forum • Draft FDA Guidance Dec 2013

Draft FDA Guidance Dec 2013 [Regulatives / Guidelines]

posted by jag009 – NJ, 2013-12-09 23:31 (4585 d 00:28 ago) – Posting: # 12027
Views: 20,290

Hi,

❝ Oops :no: New FDA states that "For applicants wishing to use variations of these study designs or analysis methods (e.g., a sequential design or scaled-average BE, we recommend that you submit a complete protocol for review and comment before starting the study", it means any Scaled Average BE protocol need to be submitted to FDA before study initiation :crying: .

Hmm.. But shouldn't one inform the agency if they elect to use a different design other than the partial/full RSABE, ABE (and others that FDA has published) anyway? Why is this a disappointment? They just don't want to think outside the box thats all (too many rules and politics to follow?).

At least they stated up front, otherwise they can reject your study at filing if they want to.

John

Complete thread:

Draft FDA Guidance Dec 2013 pash413 2013-12-04 15:05
- First impressions Helmut 2013-12-04 16:47
  - First impressions nasir 2014-02-14 06:47
- What is Bioequivalence in the US really? ElMaestro 2013-12-07 23:34
  - Site of action vs. systemic circulation Helmut 2013-12-08 02:05
- Draft FDA Guidance Dec 2013 drgunasakaran1 2013-12-08 08:39
  - Two-stage or RSABE Helmut 2013-12-08 13:59
    - Two-stage or RSABE ElMaestro 2013-12-08 14:17
      - Two-stage methods Helmut 2013-12-08 14:44
        
        Two-stage methods ElMaestro 2013-12-08 18:56
    - RSABE Lucas 2014-03-24 17:05
      - RSABE Helmut 2014-03-24 17:25
        
        RSABE Lucas 2014-03-25 13:33
        
        RSABE Helmut 2014-03-25 14:31
        
        RSABE Lucas 2014-03-26 15:19
        
        RSABE Helmut 2014-03-26 15:28
  - Draft FDA Guidance Dec 2013jag009 2013-12-09 22:31
    - Draft FDA Guidance Dec 2013 kvgreddy06 2014-02-14 16:44
- End of consultation approaching‼ Helmut 2014-02-26 11:32
  - End of consultation approaching‼ wien-ui 2014-03-01 08:05
    - End of consultation approaching‼ Helmut 2014-03-01 20:09
      - End of consultation approaching‼ wien-ui 2014-03-04 10:53