Widening for clopidogrel BE study [Outliers]

posted by mittyri – Russia, 2021-06-16 18:04 (597 d 00:27 ago) – Posting: # 22419
Views: 1,920

Dear Loky do

❝ is widening of Cmax accepted in clopidogrel BE studies with fully replicate design or not?


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.

Kind regards,
Mittyri

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