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averroes1304 ☆ Morocco, 2018-11-19 22:14 (1837 d 21:54 ago) Posting: # 19643 Views: 4,953 |
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Dear all. Is it possible to apply the biowaiver based on the BCS system for oral suspensions with systemic effect? Knowing that the guidlines announce that the BCS system is only for immediate release oral solid forms. And oral suspensions are not solid forms. Kind regards. |
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Mauricio Sampaio ★ Brazil, 2018-11-23 16:39 (1834 d 03:30 ago) @ averroes1304 Posting: # 19646 Views: 4,928 |
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Dear averroes1304 The particles of the dispersed phase of a suspension are (generally) solid insoluble in the dispersing medium. Then, it is possible to apply the biowaiver based on the BCS system for oral suspensions with systemic effect!  In conclusion: Oral suspensions are solid forms.  Best regards. |
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wienui ★ Germany/Oman, 2018-11-23 20:36 (1833 d 23:33 ago) @ averroes1304 Posting: # 19648 Views: 4,278 |
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Dear averroes1304, ❝ Is it possible to apply the biowaiver based on the BCS system for oral suspensions with systemic effect? Yes, if you apply for EU region ,WHO & some other countries No for USA & some other countries Please refer to this article, https://www.ncbi.nlm.nih.gov/pubmed/29382433 Best regards, Osama — Cheers, Osama |
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Mauricio Sampaio ★ Brazil, 2018-11-26 19:17 (1831 d 00:51 ago) @ wienui Posting: # 19652 Views: 4,189 |
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Dear Osama ❝ No for USA & some other countries ❝ Why not? The article ( https://www.ncbi.nlm.nih.gov/pubmed/29382433) does't explain the reason! Do you know? Best regards |
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wienui ★ Germany/Oman, 2018-11-27 04:50 (1830 d 15:18 ago) (edited by wienui on 2018-11-28 03:01) @ Mauricio Sampaio Posting: # 19653 Views: 4,201 |
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Dear Mauricio, ❝ Why not? The article ( https://www.ncbi.nlm.nih.gov/pubmed/29382433) does't explain the reason! Do you know? There are a lot of differences between the global jurisdictions, some of them referred to different scientific opinions ( which I can accept it) on the other hand a lot of them you can't find any scientific reasons behind at all. Guidelines ( Guidances) are made from Human, who are different and harmoni(s)zation will still be not achievable dream. Plz. s. this post from Helmut, https://forum.bebac.at/mix_entry.php?id=12529#p12535. I'm myself inclined to the Pro- waiving of semisolid dosage form. Best regards, Osama — Cheers, Osama |
Ing. Helmut Schütz