Bioequivalence and Bioavailability Forum • clopidogrel

clopidogrel [Design Issues]

posted by velupharm – 2007-03-30 18:58 (7022 d 17:56 ago) – Posting: # 606
Views: 12,087

Dear all
we are developing clopidogrel formulation.
As far as the European regulatory point of view, can we prove BE only with its inactive metabolite, as clopidogrel itself becomes BLQ after 2hrs post dose (As Per SmPC)?

Complete thread:

clopidogrelvelupharm 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