Control of N-nitrosamine impurities in drug products: Progressing the current CPCA framework and supporting the derivation of robust compound specific acceptable intakes

Autor: Ponting, David J., Czich, Andreas, Felter, Susan P., Glowienke, Susanne, Harvey, James S., Nudelman, Raphael, Schlingemann, Joerg, Simon, Stephanie, Smith, Graham F., Teasdale, Andrew, Thomas, Robert
Zdroj: In Regulatory Toxicology and Pharmacology February 2025 156
Databáze: ScienceDirect