Bioequivalence and Bioavailability Forum • clopidogrel bioequivalence

clopidogrel bioequivalence - PD endpoint [Design Issues]

posted by drks – 2007-05-29 09:53 (6964 d 17:44 ago) – Posting: # 751
Views: 11,219

Dear All,

❝ 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)?

Considering the difficulties with clopidogrel BE estimation,

is it possible that the BE assessment be done on the basis of PD end points?
Can platelet aggregation be utilised for estimating the bioequivalence of the clopidogrel?
and most important, has there been any submission (and approval) of clopidogrel formulation to any regulatory agency?

I am aware that there are good methods for the estimation of clopidogrel now. However, we are exploring the possibility of PD studies to help in BE estimation of these formulations and i would appreciate if anybody could help in this regard.

Helmut, please share your comments on this.

best regards
kshitij

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 endpointdrks 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