BCS Biowaiver for oral suspension [Dissolution / BCS / IVIVC]

posted by wienui  – Germany, Oman, 2018-11-23 19:36 (881 d 17:09 ago) – Posting: # 19648
Views: 3,317

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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