Bioequivalence and Bioavailability Forum • First impressions

First impressions [Regulatives / Guidelines]

posted by nasir – Jordan, 2014-02-14 07:47 (4514 d 00:01 ago) – Posting: # 12420
Views: 15,703

Hi Helmut,

I know this is a bit late comment.

But I draw your attention that draft guidance is focusing on plasma matrix. It should be more general to any validated body matrix (e.g. urine, saliva...etc, and I have sent this to FDA.

Nasir

Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]

Complete thread:

Draft FDA Guidance Dec 2013 pash413 2013-12-04 15:05
- First impressions Helmut 2013-12-04 16:47
  - First impressionsnasir 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 2013 jag009 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