Dr_Dan ★★ Germany, 2017-05-24 20:56 (2522 d 14:47 ago) Posting: # 17406 Views: 4,500 |
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Hi everybody Biowaivers face a lot of rejection. Has anybody gained experience submitting a biowaiver request comparing a medicinal product containing the salt of an API against another medicinal product (same pharmaceutical form) with the co-crystal of the same API? Looking forward to your valuable replies. Thanks in advance. — Kind regards and have a nice day Dr_Dan |
nobody nothing 2017-05-24 22:21 (2522 d 13:21 ago) @ Dr_Dan Posting: # 17409 Views: 3,868 |
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Hi Doc! Talking about EU? And BCS-based biowaivers? The EU Guideline is crystal clear, for different salts: Both have to be BCS-class I. Do you have all data necessary to prove? Otherwise, maybe a waste of time. That's why biowaivers are not so easy, in my opinion, you need some (non-standard) data like solubility over pH (and at pKa) and maybe some permeability data not at hand (at sufficient detail) for generics from published literature... I think often people go the "known" way, BE-study, end of game. Instead of investing time (!) and money for a task with unknown outcome. On the other hand, if you have enough data before going for a SA you might be able to convince authorities. Edit: Please don’t shout! [Helmut] — Kindest regards, nobody |
Dr_Dan ★★ Germany, 2017-05-29 11:16 (2518 d 00:26 ago) @ nobody Posting: # 17423 Views: 3,665 |
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Hi nobody ❝ Talking about EU? And BCS-based biowaivers? ❝ The EU Guideline is crystal clear, for different salts: Both have to be BCS-class I. CPMP/EWP/QWP/1401/98 Rev. 1/ Corr ** states: Biowaiver is not applicable when the test product contains a different ester, ether, isomer, mixture of isomers, complex or derivative of an active substance from that of the reference product, since these differences may lead to different bioavailabilities not deducible by means of experiments used in the BCS-based biowaiver concept. ❝ I think often people go the "known" way, BE-study, end of game. Instead of investing time (!) and money for a task with unknown outcome. — Kind regards and have a nice day Dr_Dan |
nobody nothing 2017-05-29 12:15 (2517 d 23:27 ago) @ Dr_Dan Posting: # 17424 Views: 3,692 |
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Hi again! For one second assume your "cocrystal" is a different salt according to EMA guide. REF and cocrystal both Class 1? If the answer is no: End of story. (Guess this is applicable here, as in many other cases, due to lack of data). If yes: Go with sufficient details for a SA and ask as one question if your cocrystal is a different "salt" for the authority when it comes to a BCS biowaiver. But be prepared to get an answer as like trying to "den Pudding an die Wand nageln...". If your sponsor is interested in timelines, he will do the BE-study and go on, I guess. — Kindest regards, nobody |