Reference drugs for triple combination test drug in Russia [Design Issues]

posted by PharmCat  – Russia, 2019-11-15 20:07 (379 d 00:54 ago) – Posting: # 20809
Views: 3,168

» Hi PharmCat!

»
» Why second is wrong?

If you look at federal law, you can find:

generic drug - a drug that has the same qualitative composition and quantitative composition of active substances in the same dosage form as the reference drug, and whose bioequivalence or therapeutic equivalence is confirmed by the reference drug with relevant studies.

That why I said "strictly", triple FDC can be compared with similar registered triple FDC.

Anyway can be some exceptions when this rule not work. May be it can be orphan drugs or some individual cases or regulatory abuse.

You mention clinical trial with HIV drug and 280 subjects in 2 sites - may be this is exception.

In general case you can do BE vs equal FDS or therapeutic equivalence.

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