With all discussions going around about different methodologies applied by different jurisdiction regulators for “Accetable Intake” Derivation for NDSRI complex nitrosamine. Regulators already have in house and cross country/region regulators colloboration projects in place which would take some time up to 1 year to finish. Considering large number of susceptible API and formulations, it is complex. So in early 2024, we may expect some draft guidance which may help in methodology harmonisation in AI derivation for complex nitrosamines.
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