Bioequivalence and Bioavailability Forum • Widening for clopidogrel BE study

Widening for clopidogrel BE study [Outliers]

posted by Loky do – Egypt, 2021-06-16 19:08 (718 d 06:31 ago) – Posting: # 22420
Views: 2,019

❝ 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.

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)?
thanks

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 studyLoky 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