Neotron, in collaboration with a guest speaker from Innovatune, invites you to a webinar on 24 July 2025 at 11:00 A.M. CEST.
Regulators worldwide now scrutinise N-nitrosamine impurities because of their potent carcinogenic potential, structural diversity and unexpected appearance in finished drug products. Yet robust compound specific carcinogenicity data are often lacking—especially for nitrosamine drug substance related impurities (NDSRIs).
Neotron, in collaboration with a guest expert from Innovatune presents, an end-to-end strategy that unites three critical pillars:
1. Toxicological Risk Assessment (Up front)
- Carcinogenic Potency Categorisation Approach (CPCA): how to place data poor nitrosamines into potency bins and select conservative reference values.
- Read Across & Analogue Selection: leveraging structurally related compounds to justify Acceptable Intakes (AIs) when direct data are absent.
- In Silico & QSAR Tools: integrating computational alerts and metabolic activation models to strengthen toxicological arguments in line with current guidance.
2. Process Centred Risk Assessment: A systematic review of manufacturing steps, raw materials, solvents and auxiliary agents to map where nitrosamines or their precursors can form and to prioritise which impurities warrant control.
3. Targeted Analytical Testing: Translating the risk analysis into fit for purpose screening and confirmatory methods—thereby focusing laboratory resources on the impurities most likely to pose a real threat.
By aligning toxicological justification, process knowledge and analytical evidence, companies can assemble a defensible, regulator ready control package that avoids over testing while safeguarding patient safety.
Join us to see how this integrated workflow streamlines nitrosamine management and accelerates dossier preparation for health authority submission.
Don’t miss the opportunity to be part of this impactful session. To secure your spot,click here to register.