Bioequivalence and Bioavailability Forum

Supportive data? [Design Issues]

posted by Ohlbe – France, 2009-07-31 21:48 (6174 d 23:38 ago) – Posting: # 4004
Views: 9,282

Dear ElMaestro and Helmut,

❝ Last January in Bonn I asked [...] what ‘supportive’ actually means.

To make it short: you can do it if you have money to waste

❝ ❝ In fact I could be afraid we are getting to a point where supportive data could not be used by an applicant to claim BE but could be used by regulators as basis for rejections.

Agreed.

Regards
Ohlbe

Complete thread:

• clopidogrel velupharm 2007-03-30 16:58 
  • clopidogrel Ohlbe 2007-03-30 17:44
  • clopidogrel Imran 2007-04-11 10:54
  • clopidogrel bioequivalence - PD endpoint drks 2007-05-29 07:53
    • clopidogrel bioequivalence - PD endpoint Helmut 2007-05-29 11:47
      • clopidogrel bioequivalence - PD endpoint drks 2007-05-30 10:13
        • clopidogrel bioequivalence - PD endpoint Helmut 2007-05-30 12:47
      • clopidogrel bioequivalence - PD endpoint lukamar 2009-01-13 11:56
        • clopidogrel bioequivalence - PD endpoint lukamar 2009-01-19 10:33
          • clopidogrel active metabolite Ohlbe 2009-01-21 23:42
            • Current EU-position Helmut 2009-07-31 14:24
              • Supportive data? ElMaestro 2009-07-31 19:10
                • Supportive data? Helmut 2009-07-31 19:39
                  • Supportive data?Ohlbe 2009-07-31 19:48
      • clopidogrel bioequivalence - PD endpoint lukamar 2009-01-13 12:35
        • clopidogrel bioequivalence - PD endpoint Helmut 2009-01-14 14:33
        • clopidogrel bioequivalence - PD endpoint Ohlbe 2009-01-17 17:57
    • clopidogrel bioequivalence - PD endpoint drdds 2007-06-04 09:08
    • clopidogrel bioequivalence - PD endpoint ElMaestro 2009-01-14 17:22