back conversion test [Regulatives / Guidelines]

posted by Thair Saleh – Jordan, 2024-07-01 11:42 (16 d 15:22 ago) – Posting: # 24050
Views: 312

dear Colleagues

in the case of metabolites, (unstable N-oxides or glucuronide metabolites, lactone-ring structures) found in the drug should always covered by the back conversion test, or there is a limit (2%, 5%, 10%) of the drug if the metabolite exceeds then should be covered.

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