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

posted by Beholder  – Russia, 2019-11-18 10:13 (519 d 16:09 ago) – Posting: # 20819
Views: 3,428

» 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.

PharmCat, if we take triple combination e.g. Losartan 100 mg/Amlodipine 5 mg/Rosuvastatin 20 mg (mittyri`s real example) and following reference drugs Losartan 100 mg/Amlodipine 5 mg and Rosuvastatin 20 mg than still the compared drugs have the same qualitative composition and quantitative composition of active substances in the same dosage form as the reference drug as you said. it is still losartan 100 mg whenever you take it.

Best regards
Beholder

Complete thread:

Activity
 Admin contact
21,419 posts in 4,475 threads, 1,510 registered users;
online 7 (0 registered, 7 guests [including 3 identified bots]).
Forum time: Wednesday 03:23 CEST (Europe/Vienna)

In the Middles Ages the lingua franca of science was Latin.
Nowadays the language of science is bad English.    Anonymous

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5