On the role of digital tools in nitrosamine risk assessment for drug substance and drug product manufacturing processes
A Eren, D Moon, T Curran, C Luciani - Current Opinion in Chemical …, 2024 - Elsevier
Highlights•The development of digital tools is vital to quantify nitrosamines acceptable
intake, rate of generation, and purge.•Solution-phase kinetic models are used to determine …
intake, rate of generation, and purge.•Solution-phase kinetic models are used to determine …