BE study for an FDC [Regulatives / Guidelines]

posted by Phaneendra.K – 2011-02-01 17:25 (5626 d 11:04 ago) – Posting: # 6529
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If i want to formulate a new FDC in which one is of a newer molecule ..
example.. say for an indication there is an innovator FDC of LISINOPRIL + X.
For the same indication if i formulate PERINDOPRIL + X among which Lisinopril and perindopril are of the same category.. do i have to conduct a BE study or a clinical trial..
—
Thanks and Regards,

PK

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