Bioequivalence and Bioavailability Forum • Widening for clopidogrel BE study

Widening for clopidogrel BE study - cherry-picking? [Outliers]

posted by mittyri – Russia, 2021-06-16 19:27 (1480 d 13:26 ago) – Posting: # 22421
Views: 8,529

Dear Loky do,

❝ Ok, in my case, the study fails as per EMA guidance, but if we used the FDA method for calculations it passes, regarding a drug as clopidogrel with many therapeutic issues, could it be accepted by different authorities, considering FDA guidelines (sponsor requests to submit an appeal to authorities to use calculations as per FDA guidelines as the protocol uses EMA guidance for statistical calculations)?

The product-specific guidance is quite old and was issued before RSABE first appeared as an option.
BTW that smells like cherry-picking, sorry
Most probably it will be rejected taking into account audit trail of the Protocol changes/dates of analysis.

—
Kind regards,
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 study Loky 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