We were thrilled to be joined by a distinguished panel of experts to discuss how to establish acceptable intake (AI) limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs).
NDSRIs have emerged as a significant cause for concern within the pharmaceutical industry due to their potential to pose serious health risks to patients. In order to facilitate nitrosamine safety assessments, regulatory bodies such as the US FDA, EMA, and Health Canada have issued guidelines outlining recommended AI limits for NDSRIs. In this webinar, we will explore nitrosamine safety assessment and discuss strategies to facilitate regulatory compliance within the pharmaceutical industry.
Dr Martin Walter, Non-Clinical Assessor at the Austrian Medicines and Medical Devices Agency presented on nitrosamine safety assessment and the most recent updates issued by the EMA surrounding the Enhanced Ames Test (EAT) and Carcinogenic Potency Categorisation Approach (CPCA).
Dr Raphael Nudelman, Senior Director Impurity Expert from Teva discussed the bacterial reverse mutation (Ames) test in relation to nitrosamines, using read-across assessment to determine suitable surrogates for higher AI limits and the complex nitrosamines data sharing initiative.
Dr David Ponting, Principal Scientist at Lhasa Limited presented on Lhasa’s recent work surrounding read-across and the current nitrosamine related data sharing initiatives Lhasa has to offer.