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

posted by PharmCat  – Russia, 2019-11-15 20:07 (520 d 14:17 ago) – Posting: # 20809
Views: 3,511

» 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.

Complete thread:

 Admin contact
21,419 posts in 4,475 threads, 1,510 registered users;
online 4 (0 registered, 4 guests [including 2 identified bots]).
Forum time: Monday 11:25 CEST (Europe/Vienna)

There is one certainty in drug development
and statistics that one can depend on:
the data are always late.    Scott Patterson and Byron Jones

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz