Where can N-Nitrosamine data support an alternative AI beyond the CPCA?
The recently published paper “Control of N-nitrosamine impurities in drug products: Progressing the current CPCA framework and supporting the derivation of robust compound specific acceptable intakes,” presents evidence for evolving the pharmaceutical industry’s approach to N-nitrosamine risk assessment. While the Carcinogenic Potency Categorisation Approach (CPCA) has provided a solid framework for managing N-nitrosamine drug substance-related […]
Where can N-Nitrosamine data support an alternative AI beyond the CPCA? Read More »
