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

posted by mittyri – Russia, 2021-06-16 17:27 (340 d 16:38 ago) – Posting: # 22421
Views: 1,503

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

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