Journal of Pharmaceutical Sciences is dedicating a Special Issue to the topic of nitrosamine impurities in drugs. The intention of this special issue is to provide a broad array of in-depth content based on research articles and reviews on the topic. Publications will include perspectives from all required disciplines such as API and drug product manufacturing, packaging, analytics, toxicology, risk assessment methodologies as well as regulatory aspects. Planned and encouraged publications for contribution will include, but not be limited to studies addressing reactivity factors for potential vulnerable amines, formation, occurrence and driving risk factors in drug products and packaging, modeling approaches and application to risk assessments, regulatory frameworks to addressing risk within the principles laid out in harmonized guidances (e.g ICH Q9), analytical methodologies to improved detection of N-nitrosamines as well as toxicological aspects.
Potential authors are encouraged to submit for publication to this special edition.