Acceptable intakes (AIs) for 11 small molecule N-nitrosamines (NAs).

Animals Nitrosamines / toxicity Carcinogens Structure-Activity Relationship Pharmaceutical Preparations

Journal

Regulatory toxicology and pharmacology : RTP
ISSN: 1096-0295
Titre abrégé: Regul Toxicol Pharmacol
Pays: Netherlands
ID NLM: 8214983

Informations de publication

Date de publication:
Aug 2023
Historique:
received: 23 02 2023
revised: 21 04 2023
accepted: 07 05 2023
medline: 17 7 2023
pubmed: 1 6 2023
entrez: 31 5 2023
Statut: ppublish

Résumé

Low levels of N-nitrosamines (NAs) were detected in pharmaceuticals and, as a result, health authorities (HAs) have published acceptable intakes (AIs) in pharmaceuticals to limit potential carcinogenic risk. The rationales behind the AIs have not been provided to understand the process for selecting a TD

Identifiants

DOI: 10.1016/j.yrtph.2023.105415 PMID: 37257751
pubmed: 37257751
pii: S0273-2300(23)00083-1
doi: 10.1016/j.yrtph.2023.105415
pii:
doi:

Substances chimiques

Nitrosamines 0
nas 64706-31-6
Carcinogens 0
Pharmaceutical Preparations 0

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

105415

Informations de copyright

Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests:There are authors and co-authors employed by pharmaceutical companies.

Auteurs

Joel P Bercu (JP)

Gilead Sciences, Inc., Nonclinical Safety and Pathobiology (NSP), Foster City, CA, USA. Electronic address: joel.bercu@gilead.com.

Melisa Masuda-Herrera (M)

Gilead Sciences, Inc., Nonclinical Safety and Pathobiology (NSP), Foster City, CA, USA.

Alejandra Trejo-Martin (A)

Gilead Sciences, Inc., Nonclinical Safety and Pathobiology (NSP), Foster City, CA, USA.

Priyanka Sura (P)

Gilead Sciences, Inc., Nonclinical Safety and Pathobiology (NSP), Foster City, CA, USA.

Robert Jolly (R)

Eli Lilly and Company, Indianapolis, IN, USA.

Michelle Kenyon (M)

Pfizer Worldwide Research, Development and Medical, Drug Safety Research and Development, Groton, CT, USA.

Rob Thomas (R)

Lhasa Limited, Leeds, UK.

David J Ponting (DJ)

Lhasa Limited, Leeds, UK.

David Snodin (D)

Xiphora Biopharma Consulting, Bristol, UK.

Gregor Tuschl (G)

Merck KGaA, Global Chemical and Preclinical Safety, Darmstadt, Germany.

Stephanie Simon (S)

Merck KGaA, Global Chemical and Preclinical Safety, Darmstadt, Germany.

Kathleen De Vlieger (K)

Janssen Research & Development, Beerse, Antwerp, Belgium.

Richard Hutchinson (R)

Janssen Research & Development, Spring House, PA, USA.

Andreas Czich (A)

Sanofi, R&D Preclinical Safety, Frankfurt, Germany.

Susanne Glowienke (S)

Novartis AG, NIBR, Klybeckstrasse, Basel, Switzerland.

M Vijayaraj Reddy (MV)

Merck Research Laboratories, West Point, PA, USA.

Sandra Johanssen (S)

Bayer AG, Pharmaceuticals, Research & Development, Berlin, Germany.

Esther Vock (E)

Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany.

Nancy Claude (N)

Servier Paris-Saclay R&D Institute, Gif-sur-Yvette, France.

Richard J Weaver (RJ)

Servier Paris-Saclay R&D Institute, Gif-sur-Yvette, France.

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Classifications MeSH

questionsmedicales.fr › Eucaryotes › Animaux › Acceptable intakes (AIs) for 11 small molecule...
questionsmedicales.fr › Composés chimiques organiques › Composés nitrosés › Nitrosamines › Acceptable intakes (AIs) for 11 small molecule...
questionsmedicales.fr › Actions chimiques et utilisations › Actions toxiques › Noxas › Cancérogènes › Acceptable intakes (AIs) for 11 small molecule...
questionsmedicales.fr › Phénomènes physiologiques › Phénomènes pharmacologiques et toxicologiques › Phénomènes pharmacologiques › Relation structure-activité › Acceptable intakes (AIs) for 11 small molecule...
questionsmedicales.fr › Préparations pharmaceutiques › Acceptable intakes (AIs) for 11 small molecule...