Widening for clopidogrel BE study [Outliers]

posted by Loky do – Egypt, 2021-06-16 17:08 (172 d 23:03 ago) – Posting: # 22420
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» 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

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