Bioequivalence and Bioavailability Forum • clopidogrel bioequivalence

clopidogrel bioequivalence - PD endpoint [Design Issues]

posted by ElMaestro – Denmark, 2009-01-14 18:22 (6371 d 00:22 ago) – Posting: # 3030
Views: 9,770

Dear kshitij,

❝ 2. Can platelet aggregation be utilised for estimating the bioequivalence of the clopidogrel?

It might be possible, in which case you would probably have to give reasonable proof that your method gives better chance of detecting a clin. meaningful difference than if you evaluate the PK of parent compound, metabolites etc.
How on earth you can do this I cannot tell. But in case you try I would be the first to gamble on a referral at my local bookmaker.

Best regards
EM.

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 endpointElMaestro 2009-01-14 17:22