Bioequivalence and Bioavailability Forum • Widening for clopidogrel BE study

Widening for clopidogrel BE study [Outliers]

posted by mittyri – Russia, 2021-06-16 16:04 (125 d 07:23 ago) – Posting: # 22419
Views: 1,120

Dear Loky do

» is widening of Cmax accepted in clopidogrel BE studies with fully replicate design or not?

You linked the EMA Q&A where it is stated unequivocally:
Under these circumstances, the widening of 90% confidence intervals for Cmax is not recommended.

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Kind regards,
Mittyri

Complete thread:

Outlier in fully replicate BE study Loky do 2021-06-16 00:49 [Outliers]
- Outlier in fully replicate BE study drgunasakaran1 2021-06-16 08:59
  - Widening for clopidogrel BE study Loky do 2021-06-16 15:38
    - Widening for clopidogrel BE studymittyri 2021-06-16 16:04
      - Widening for clopidogrel BE study Loky do 2021-06-16 17:08
        
        Widening for clopidogrel BE study - cherry-picking? mittyri 2021-06-16 17:27
        Widening for clopidogrel BE study drgunasakaran1 2021-06-17 12:01
        Hypotheses Helmut 2021-06-19 12:32
        
        Hypotheses Loky do 2021-07-06 11:51
        
        ABEL ≠ RSABE Helmut 2021-07-06 16:17