Bioequivalence and Bioavailability Forum • OGD Guidance

OGD Guidance [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2010-04-23 14:42 (5897 d 08:37 ago) – Posting: # 5198
Views: 18,705

Dear ElMaestro and D Labes,

besides your valuable suggestions have a look at FDA's Office of Generic Drugs Draft Guidance (02/2010) - which is really a weird piece of work. I can understand KR's questions - and have not the slightest idea what FDA wants here.

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

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Complete thread:

Orlistat Bioequivalence KR 2010-04-23 06:14 [Regulatives / Guidelines]
- To Abreviate or not to Abreviate d_labes 2010-04-23 09:28
  - What was really meant ElMaestro 2010-04-23 09:50
    - OGD GuidanceHelmut 2010-04-23 12:42
  - To Abreviate or not to Abreviate KR 2010-04-23 15:01
    - Calm and serene d_labes 2010-04-23 15:47
    - To Abreviate or not to Abreviate ElMaestro 2010-04-24 08:16
      - To Abreviate or not to Abreviate KR 2010-04-26 06:03
        
        To Abreviate or not to Abreviate GSTATS 2010-05-27 18:30
        
        My lack of understanding ElMaestro 2010-05-28 00:54
        
        My lack of understanding GSTATS 2010-05-28 17:03
        
        My lack of understanding ElMaestro 2010-05-29 03:32
        
        My lack of understanding GSTATS 2010-05-29 05:28
        
        My lack of understanding KR 2010-05-31 08:51
        
        My lack of understanding ElMaestro 2010-06-01 16:13
        
        Calculation sangeeta 2011-11-29 17:58
        
        Calculation ElMaestro 2011-11-29 18:09
        
        Calculation sangeeta 2011-11-29 18:30
        
        Calculation ElMaestro 2011-11-30 11:35