Article (Scientific journals)
N-nitrosamine risk assessment in pharmaceuticals: Where are we from a regulatory point of view in 2025?
Zhang, Yue; Widart, Joëlle; Ziemons, Eric et al.
2025In Journal of Pharmaceutical and Biomedical Analysis Open, 6 (December), p. 100084
Peer Reviewed verified by ORBi
 

Files


Full Text
N-nitrosamine risk assessment in pharmaceuticals - Where are we from a regulatory point of view in 2025.pdf
Publisher postprint (2.41 MB) Creative Commons License - Attribution, Non-Commercial
Download

All documents in ORBi are protected by a user license.

Send to



Details



Keywords :
N-nitrosamine impurity; Risk assessment; Carcinogenicity; Pharmaceuticals; FDA; EMA
Precision for document type :
Review article
Disciplines :
Pharmacy, pharmacology & toxicology
Author, co-author :
Zhang, Yue  ;  Université de Liège - ULiège > Unités de recherche interfacultaires > Centre Interdisciplinaire de Recherche sur le Médicament (CIRM)
Widart, Joëlle ;  Université de Liège - ULiège > Département de pharmacie
Ziemons, Eric  ;  Université de Liège - ULiège > Unités de recherche interfacultaires > Centre Interdisciplinaire de Recherche sur le Médicament (CIRM)
Hubert, Philippe  ;  Université de Liège - ULiège > Unités de recherche interfacultaires > Centre Interdisciplinaire de Recherche sur le Médicament (CIRM)
Hubert, Cédric  ;  Université de Liège - ULiège > Unités de recherche interfacultaires > Centre Interdisciplinaire de Recherche sur le Médicament (CIRM)
Language :
English
Title :
N-nitrosamine risk assessment in pharmaceuticals: Where are we from a regulatory point of view in 2025?
Publication date :
21 July 2025
Journal title :
Journal of Pharmaceutical and Biomedical Analysis Open
eISSN :
2949-771X
Publisher :
Elsevier
Volume :
6
Issue :
December
Pages :
100084
Peer reviewed :
Peer Reviewed verified by ORBi
Available on ORBi :
since 28 July 2025

Statistics


Number of views
66 (8 by ULiège)
Number of downloads
289 (1 by ULiège)

Scopus citations®
 
0
Scopus citations®
without self-citations
0
OpenCitations
 
0
OpenAlex citations
 
1

Bibliography


Similar publications



Contact ORBi