Nitrosamine Risk Assessments in Oligonucleotides

The European Medicines Agency, the U.S. Food and Drug Administration, other regulatory agencies expect that all pharmaceutical products be assessed for potential presence of N-nitrosoamine (nitrosamine) impurities. This white paper addresses general considerations nitrosamine risk assessments oligonucleotide products. authors propose a assessment platform which should facilitate safe, consistent development new treatments alignment with expectations.