Widening for clopidogrel BE study [Outliers]

posted by drgunasakaran1  – 2021-06-17 14:01 (1101 d 00:00 ago) – Posting: # 22422
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Dear Mr 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)?


Most of the times, the regulatory agency may not accept the change in the statistical plan after the Statistical Evaluation for the reason since it fails as per EMA guidance.

Dr S Gunasakaran MBBS MD
Disclaimer: The replies/posts are my personal opinions and it does not represent my company views on the same.

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