Bioequivalence and Bioavailability Forum

Supportive data? [Design Issues]

posted by Helmut  – Vienna, Austria, 2009-07-31 21:39 (6175 d 18:33 ago) – Posting: # 4003
Views: 9,367

Dear ElMaestro,

your first paragraph is a perfect aggregation.

❝ Because of this it is difficult for me to understand what supportive data are or when they become handy or make a difference. 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.

Last January in Bonn I asked Jan Welink what ‘supportive’ actually means. He said: ‘Only means ±SD, plasma profiles, etc. – no calculation of a point estimate and con­fidence interval.’ The other six members of the PK-group on the panel agreed. No dis­agreement from the Austrian member (he was in the audience). The member from Hungary was absent; no idea about the French one (anonymous). So what it is it for? Back to eye-ball pharmacokinetics (‘Well, that's a nice curve – but look at the strange secondary peak at 12 hours…’)!

❝ Anyone else been thinking thoughts like this, …

Looking for a passionate heretic - gimme a call!

❝ … or am I alone in the universe?

Don’t know – have you ever considered joining SETI?

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


The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

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    • 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