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Registerback conversion test [Regulatives / Guidelines]
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.
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.
Complete thread:
- back conversion testThair Saleh 2024-07-01 09:42
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Ing. Helmut Schütz