Bioequivalence and Bioavailability Forum • Very strange!

Very strange! [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2013-08-05 18:37 (4705 d 21:27 ago) – Posting: # 11209
Views: 6,265

Hi John,

❝ […] FDA wants 3 studies, 2 of which are RSABE studies on 90 mg the RLD, and 1 fasting on 60 mg (? It's not RLD, huh?) So 90 mg is HVD and 60 mg is not HVD?

60 mg not RLD is strange indeed. I guess you misinterpreted the guidance. For the 60 mg fasting study I read: “Additional Comments: Please see comments [sic] above.“ Since they cannot mean the comment on fed studies, this leaves only the 90 mg fasting study with a reference to the progesterone guidance (=HVD…).

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Complete thread:

BE using non RLD zheng791 2013-08-03 21:45
- BE using non RLD ElMaestro 2013-08-03 22:17
  - BE using non RLD jag009 2013-08-03 22:51
    - BE using non RLD zheng791 2013-08-03 23:55
      - BE using non RLD jag009 2013-08-04 20:20
        
        BE using non RLD luvblooms 2013-08-05 05:57
        
        BE using non RLD ElMaestro 2013-08-05 10:44
        
        BE using non RLD luvblooms 2013-08-05 13:46
        
        BE using non RLD ElMaestro 2013-08-05 13:59
        
        BE using non RLD luvblooms 2013-08-05 14:31
        
        BE using non RLD ElMaestro 2013-08-05 15:04
        Very strange! jag009 2013-08-05 16:02
        
        Very strange!Helmut 2013-08-05 16:37
        
        Very strange! jag009 2013-08-05 16:45
        
        Very strange! luvblooms 2013-08-05 17:30
        
        Very strange! jag009 2013-08-05 17:52