Averroes ☆ Spain, 2012-01-18 14:05 (4479 d 16:22 ago) Posting: # 7960 Views: 3,574 |
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Dear All, Hope somebody can give his/her oppinion about fulfillmet of proportional composition condition for a generic fixed combination in order to biowaive the lower strenght Higher strength Lower strength We are planning to perform bioequivalence with the higher strenght and request for biowaiver for the lower but according to EMA guideline: The conditions regarding proportional composition should be fulfilled for all active substances of fixed combinations and When considering the amount of each active substance in a fixed combination the other active substance(s) can be considered as excipients. How should this be interpreted? In this example when looking to substance A (substance B considered as an excipient), I clearly see that proportional composition condition is fulfilled (active substance is less than 5%). But what about looking substance B? Even being also under 5 % it could be interpreted that proportional composition condition is not fulfilled strictely speaking since one excipient (substance A) is not in same amount in both formulations. If they interprete in this way, biowaiver would be impossible if active substance are in different amounts like in this example. Could anybody, as per your experience, let me know how EMA regulatory authorities interprete this? Thanks in advance, |
Dr_Dan ★★ Germany, 2015-05-18 12:21 (3263 d 19:07 ago) @ Averroes Posting: # 14848 Views: 2,212 |
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Dear All, I would like to follow up Averroe's post regarding the fulfillment of proportional composition condition for a generic fixed combination in order to biowaive the lower strenght(s). If you only change the amount of one drug and the other remains the same (10/20, 20/20, 40/20) the conditions regarding proportional composition cannot be fulfilled for all active substances of fixed combinations. If you consider the drug with the fixed strength (active substance is less than 5%)as an excipient it could be interpreted that proportional composition condition is fulfilled. Could anybody, as per your experience, let me know how EMA regulatory authorities interprete this? Kind regards and thanks in advance, Dr_Dan — Kind regards and have a nice day Dr_Dan |
ElMaestro ★★★ Denmark, 2015-05-18 16:38 (3263 d 14:50 ago) @ Dr_Dan Posting: # 14849 Views: 2,232 |
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Hi Averroes and Dr_Dan, ❝ Could anybody, as per your experience, let me know how EMA regulatory authorities interprete this? It is a situation that is not covered by the guideline. And as such I am not sure there is one solution that is guaranteed to work with a high probability across man agencies. Therefore, get scientific advice and apply lots of common sense in the briefing document. I know the issue of common sense is subject to much debate and confusion but in this regard I think it should imply scientifically balanced views and not just quick and cheap approval. — Pass or fail! ElMaestro |