A Phase-Appropriate Risk Assessment Strategy in Support of the Safety of Peptide and Oligonucleotide-Related Impurities - Pack, Brian W.; Siegel, Robert W.; Cornwell, Paul D.; Ferrante, Andrea; Roepke, Douglas A.; Hodsdon, Michael E.; Malherbe, Laurent; Carfagna, Mark A. (The AAPS journal, 2025)
Keywords: Amino acids; Animals; Biochemistry; Biomedical and Life Sciences; Biomedicine; Biotechnology; Clinical trials; Drug Contamination - prevention & control; Humans; Independent regulatory commissions; Medical research; Medicine, Experimental; Oligonucleotides - adverse effects; Oligonucleotides - chemistry; Oligonucleotides - toxicity; Peptides - adverse effects; Peptides - chemistry; Peptides - toxicity; Pharmaceutical industry; Pharmacology/Toxicology; Pharmacy; Proteins; Risk assessment; Risk Assessment - methods; Safety and security measures; Tutorial; toxicity; chemistry manufacturing and control; analytical control strategy; oligonucleotide-Related Impurities; peptide-Related Impurities; immunogenicity