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

posted by Beholder  – Russia, 2019-11-18 11:13 (1790 d 18:08 ago) – Posting: # 20819
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❝ 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.
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Best regards
Beholder

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