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

posted by wienui  – Germany/Oman, 2018-11-23 20:36 (1977 d 16:25 ago) – Posting: # 19648
Views: 4,536

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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