Ezetimibe BE [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2019-09-30 17:26 (1759 d 08:42 ago) – Posting: # 20657
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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.

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