Lv2
124 积分 2026-07-09 加入
Control of N-nitrosamine impurities in drug products: Progressing the current CPCA framework and supporting the derivation of robust compound specific acceptable intakes
1个月前
已完结
Risk assessment and management strategy of two new NDSRIs in a pharmaceutical drug product for the treatment of a rare disease: From prediction to control
2个月前
已完结
Using N‐Nitrosodiethanolamine (NDELA) and N‐Nitrosopiperidine (NPIP) Transgenic Rodent Gene Mutation Data and Quantum Mechanical Modeling to Derive Potency‐Based Acceptable Intakes for NDSRIs Lacking Robust Carcinogenicity Data
2个月前
已完结
N-Nitrosamine drug substance related impurities (NDSRIs) – A proposal for the addition of subcategories to carcinogenic potency categorization approach categories 1 and 2 for NDSRIs with a molecular weight > 200 Da
2个月前
已完结
Quantum Mechanical Assessment of Nitrosamine Potency
2个月前
已完结
Genotoxicity evaluation of ten nitrosamine drug substance-related impurities using 2D and 3D HepaRG cell models
2个月前
已完结
Bumetanide as a Model NDSRI Substrate: N-nitrosobumetanide Impurity Formation and its Inhibition in Bumetanide Tablets
2个月前
已完结
Mutagenic impurities in pharmaceuticals: A critical assessment of the cohort of concern with a focus on N-nitrosamines
2个月前
已完结
An automated carcinogenic potency categorization approach for nitrosamine drug substance-related impurities
2个月前
已完结
Simulation of nitrosamine drug substance-related impurities from secondary amine-related impurities in approved human drug products
2个月前
已完结
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