Publication by Borths et all " Nitrosamine Risk Assessments in Oligonucleotides"
Open Access: https://pubs.acs.org/doi/10.1021/acs.oprd.2c00330
The European Medicines Agency, the U.S. Food and Drug Administration, and other regulatory agencies expect that all pharmaceutical products be assessed for the potential presence of N -nitrosoamine (nitrosamine) impurities. This white paper addresses general considerations for nitrosamine risk assessments of oligonucleotide products. The authors propose a general risk assessment platform which should facilitate safe, consistent development of new treatments and alignment with regulatory expectations.