Bioequivalence and Bioavailability Forum • clopidogrel

clopidogrel [Bioanalytics]

posted by Ohlbe – France, 2010-08-10 18:12 (5781 d 08:02 ago) – Posting: # 5764
Views: 9,655

Dear Ioanam,

❝ The mean value obtained in the study is around 5 - 6 ng/ml for both products.

What was the dose in your study ? 75 mg, 150 mg ?

Look at the data in EPAR on EMA's web site (values for the reference product):

Clopidogrel 1A Pharma: 901 ± 1096 pg/ml
Apotex/Mylan: 794 ± 975 pg/ml (the CV for the test is even higher: 155 %)
DURA: 981 ± 1001 pg/ml
TAD: 2609 ± 855 pg/ml
Teva: not clear in the EPAR ! 935 pg/ml ? I'm not sure what the SD is.

For all trials:

the mean result is much lower than yours (but again, did you work with 75 mg or 150 mg ?), which could indicate you had a problem with back-conversion
there is a very high between-subject variability (CV higher than 100 % for at least 3 studies, possibly 4), and a highest result around 18 for a mean Cmax around 6 may happen.

How many subjects did you have in your study ? How many Cmax values above 10 do you get ? What is the median Cmax ?

—
Regards
Ohlbe

Complete thread:

clopidogrel ioanam 2010-08-10 10:42 [Bioanalytics]
- clopidogrel Dr_Dan 2010-08-10 11:21
  - clopidogrel ioanam 2010-08-10 11:28
  - clopidogrel ioanam 2010-08-10 11:43
    - clopidogrel Ohlbe 2010-08-10 12:17
- clopidogrel ioanam 2010-08-10 14:13
  - clopidogrel Ohlbe 2010-08-10 14:59
    - clopidogrel ioanam 2010-08-10 15:17
      - clopidogrelOhlbe 2010-08-10 16:12
        
        clopidogrel ioanam 2010-08-10 18:34
        
        clopidogrel Dr_Dan 2010-08-11 09:24
        
        clopidogrel ioanam 2010-08-11 11:08
        
        clopidogrel Ohlbe 2010-10-05 00:06

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