Bioequivalence and Bioavailability Forum • BCS Biowaiver for oral suspension

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

posted by wienui – Germany/Oman, 2018-11-23 20:36 (2308 d 03:30 ago) – Posting: # 19648
Views: 5,377

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

Complete thread:

BCS Biowaiver for oral suspension averroes1304 2018-11-19 21:14 [Dissolution / BCS / IVIVC]
- BCS Biowaiver for oral suspension Mauricio Sampaio 2018-11-23 15:39
- BCS Biowaiver for oral suspensionwienui 2018-11-23 19:36
  - BCS Biowaiver for oral suspension Mauricio Sampaio 2018-11-26 18:17
    - BCS Biowaiver for oral suspension wienui 2018-11-27 03:50