RLD identification in EU region in view of Brexit [Regulatives / Guidelines]

posted by shahajan baig  – India, 2021-09-10 18:44 (986 d 12:02 ago) – Posting: # 22565
Views: 2,033

Dear Ohlbe,

Thank you so much for your valuable response, additionally I wanted to know if there will be no RLD available in EU region for a parenteral solution so how can we proceed for biowaiver for the particular parenteral product because for biowaiver we need to prove similarity between active substances as per GUIDELINE ON THE INVESTIGATION OF BIOEQUIVALENCE (CPMP/EWP/QWP/1401/98 Rev. 1/ Corr **) which states that:

"Bioequivalence studies are generally not required if the test product is to be administered as an aqueous intravenous solution containing the same active substance as the currently approved product, However, if any excipients interact with the drug substance (e.g. complex formation), or otherwise affect the disposition of the drug substance, a bioequivalence study is required unless both products contain the same excipients in very similar quantity and it can be adequately justified that any difference in quantity does not affect the pharmacokinetics of the active substance"

So how would we proceed in such cases?? shall we proceed with an available different dosage form of the same strength??



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