Bioequivalence and Bioavailability Forum • clopidogrel active metabolite

clopidogrel active metabolite [Design Issues]

posted by Ohlbe – France, 2009-01-22 00:42 (6360 d 21:45 ago) – Posting: # 3100
Views: 9,728

Dear all,

❝ Is "sorry - we can not measure active metabolite" the only rationale for performing BE study on Clopidogrel PK only?

Just to make the discussion a bit more complex: a method for the determination of the active metabolite of clopidogrel in plasma was published recently:

Quantitative determination of clopidogrel active metabolite in human plasma
Makoto Takahashia, Henrianna Pang, Kiyoshi Kawabata, Nagy A. Farid and Atsushi Kurihara
Journal of Pharmaceutical and Biomedical Analysis, Volume 48, Issue 4, 1 December 2008, Pages 1219-1224

The LLOQ in this paper is too high to follow a full PK profile with a single dose of 75 or even 150 mg (it was applied to a single dose of 600 mg), but the method may be further refined to improve the LLOQ (the described LLOQ is 0.5 ng/ml, which is 20 or 50 times higher than what is currently achieved for unchanged clopidogrel), or used at least to study the Cmax, as suggested in the new draft EMEA guideline.

Regards
Ohlbe

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 metaboliteOhlbe 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