Bioequivalence and Bioavailability Forum

clopidogrel bioequivalence - PD endpoint [Design Issues]

posted by lukamar – Poland, 2009-01-19 11:33 (6366 d 07:15 ago) – Posting: # 3059
Views: 9,760

Hi again
Please let me ask again - any ideas how to deal with clopidogrel?
I know that internet forum is not best place for sharing such a valuable knowledge, but any kind of info will be highly appreciate.
Is "sorry - we can not measure active metabolite" the only rationale for performing BE study on Clopidogrel PK only?
I know that in theory formulation does not affect human metabolism, but if so, where idea of measuring metabolites comes from at first place?
I hope that I expressed my doubts clearly enough
Best regards
Łukasz

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Edit: Full quote removed. Please see this post! Helmut

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 endpointlukamar 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