Bioequivalence and Bioavailability Forum • Widening for clopidogrel BE study

Widening for clopidogrel BE study [Outliers]

posted by mittyri – Russia, 2021-06-16 18:04 (1041 d 15:35 ago) – Posting: # 22419
Views: 4,002

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.

—
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
        
        ABEL ≠ RSABE BEQool 2023-10-09 14:47
        
        power.TOST.sim and uncertainty mittyri 2023-10-11 12:42
        
        power.TOST.sim and uncertainty BEQool 2023-10-15 11:29
        
        power.TOST.sim and uncertainty mittyri 2023-10-20 21:47
        
        Distribution of PEs Helmut 2023-10-23 10:48
        
        Distribution of PEs BEQool 2023-10-23 19:55
        
        power.TOST.sim code mittyri 2023-10-31 15:40
        
        power.TOST.sim code BEQool 2023-11-02 11:22