Disease area and mode of action as criteria to assign a default occupational exposure limit.
Drug candidate
Mode of action
Occupational exposure limit
Pharmaceutical development
Safe handling
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:
Jun 2021
Jun 2021
Historique:
received:
27
03
2020
revised:
06
12
2020
accepted:
09
02
2021
pubmed:
16
2
2021
medline:
17
11
2021
entrez:
15
2
2021
Statut:
ppublish
Résumé
In the early stages of drug research and development, there are only a few or no toxicological data available for newly synthesized small molecule drug candidates (DC). Calculation of the DC's occupational exposure limit (OEL) without toxicological data is not possible. Nevertheless, an OEL is needed to indicate the level of protection required to minimize risks for laboratory researchers and technicians. For this reason, simplified guidance is required to predict possible health hazards of DCs and their corresponding safe inhalation exposure levels. Here, we evaluated 860 drug substances (DS) with OELs calculated by Novartis and grouped the DSs by disease area (DA) and then their mode of action (MoA). 28% of the evaluated DSs (n = 242) had an OEL <10 μg/m
Identifiants
pubmed: 33587935
pii: S0273-2300(21)00031-3
doi: 10.1016/j.yrtph.2021.104891
pii:
doi:
Substances chimiques
Drugs, Investigational
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
104891Informations de copyright
Copyright © 2021 Elsevier Inc. All rights reserved.