Bioequivalence and Bioavailability Forum • Widening for clopidogrel BE study

Widening for clopidogrel BE study [Outliers]

posted by Loky do – Egypt, 2021-06-16 17:38 (1483 d 07:33 ago) – Posting: # 22418
Views: 8,581

many Thanks, drgunasakaran1 for your reply

Dears
I also have a question regarding Clopidogrel BE study design, as per ema questions and answers, is widening of Cmax accepted in clopidogrel BE studies with fully replicate design or not?

thanks in advance

Edit: link restored. [mittyri]

Complete thread:

Outlier in fully replicate BE study Loky do 2021-06-16 00:49
- Outlier in fully replicate BE study drgunasakaran1 2021-06-16 08:59
  - Widening for clopidogrel BE studyLoky do 2021-06-16 15:38
    - Widening for clopidogrel BE study mittyri 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