Ezetimibe BE [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2019-09-30 13:26  – Posting: # 20657
Views: 1,329

Hi ElMaestro,

» "The applicant should document that the enzymatic de-conjugation can be considered quantitative under assay conditions"
»
» :-D:vomit:

That would be a valid request. Has to be determined in method development & validation. No big deal, since β-glucuronidase is used for decades.

Cheers,
Helmut Schütz
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