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Back to the forum  2018-07-22 23:52 CEST (UTC+2h)

In vitro Bioequivalence for suspension ophthalmic [Regulatives / Guidelines]

posted by weidson - Brazil, 2018-04-09 20:40  - Posting: # 18658
Views: 494

Dear All,

Has anyone in this group ever performed an in vitro bioequivalence study with an ophthalmic suspension that was guided by the Guidance on Dexamethasone / tobramycin (reviewed June 2012, June 2013 and June 2016)? If yes, what is the acceptance criterion for bioequivalence? In the draft nothing is mentioned for the range of acceptance of the mortality rate of the microorganisms.

https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm308032.pdf

Thanks vary much.

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