Global Substance Registration System: consistent scientific descriptions for substances related to health.
Biological Products
/ chemistry
Databases, Chemical
Databases, Factual
Databases, Pharmaceutical
Datasets as Topic
Drugs, Investigational
/ chemistry
Humans
Internet
Nucleic Acids
/ chemistry
Polymers
/ chemistry
Prescription Drugs
/ chemistry
Proteins
/ chemistry
Public Health
/ legislation & jurisprudence
Small Molecule Libraries
/ chemistry
Software
United States
United States Food and Drug Administration
Xenobiotics
/ chemistry
Journal
Nucleic acids research
ISSN: 1362-4962
Titre abrégé: Nucleic Acids Res
Pays: England
ID NLM: 0411011
Informations de publication
Date de publication:
08 01 2021
08 01 2021
Historique:
accepted:
08
10
2020
revised:
05
10
2020
received:
13
08
2020
pubmed:
3
11
2020
medline:
29
1
2021
entrez:
2
11
2020
Statut:
ppublish
Résumé
The US Food and Drug Administration (FDA) and the National Center for Advancing Translational Sciences (NCATS) have collaborated to publish rigorous scientific descriptions of substances relevant to regulated products. The FDA has adopted the global ISO 11238 data standard for the identification of substances in medicinal products and has populated a database to organize the agency's regulatory submissions and marketed products data. NCATS has worked with FDA to develop the Global Substance Registration System (GSRS) and produce a non-proprietary version of the database for public benefit. In 2019, more than half of all new drugs in clinical development were proteins, nucleic acid therapeutics, polymer products, structurally diverse natural products or cellular therapies. While multiple databases of small molecule chemical structures are available, this resource is unique in its application of regulatory standards for the identification of medicinal substances and its robust support for other substances in addition to small molecules. This public, manually curated dataset provides unique ingredient identifiers (UNIIs) and detailed descriptions for over 100 000 substances that are particularly relevant to medicine and translational research. The dataset can be accessed and queried at https://gsrs.ncats.nih.gov/app/substances.
Identifiants
pubmed: 33137173
pii: 5952203
doi: 10.1093/nar/gkaa962
pmc: PMC7779023
doi:
Substances chimiques
Biological Products
0
Drugs, Investigational
0
Nucleic Acids
0
Polymers
0
Prescription Drugs
0
Proteins
0
Small Molecule Libraries
0
Xenobiotics
0
Types de publication
Journal Article
Research Support, N.I.H., Intramural
Research Support, U.S. Gov't, P.H.S.
Langues
eng
Sous-ensembles de citation
IM
Pagination
D1179-D1185Informations de copyright
Published by Oxford University Press on behalf of Nucleic Acids Research 2020.
Références
Nat Chem. 2018 Jun;10(6):615-624
pubmed: 29784991
J Altern Complement Med. 2018 Jul;24(7):694-700
pubmed: 29641247
AMIA Annu Symp Proc. 2005;:1108
pubmed: 16779395
J Med Chem. 2011 Oct 27;54(20):7005-22
pubmed: 21848318
Multidiscip Respir Med. 2018 May 7;13:12
pubmed: 29760915
Future Virol. 2009;4(6):621-635
pubmed: 20198110
PDA J Pharm Sci Technol. 1997 Jul-Aug;51(4):166-71
pubmed: 9277127
Org Lett. 2018 Jul 6;20(13):3736-3740
pubmed: 29909639
Mol Ecol. 2016 Jan;25(2):616-29
pubmed: 26607306
Curr Med Chem. 2018 Feb 12;25(4):437-461
pubmed: 28554319
Front Med (Lausanne). 2017 Jul 21;4:114
pubmed: 28785556
Vaccine X. 2019 Jan 29;1:100009
pubmed: 31384731
J Virol. 2014 Jan;88(1):99-109
pubmed: 24131711
J Med Chem. 2018 Aug 09;61(15):6858-6868
pubmed: 30015489
Am J Hosp Pharm. 1990 Dec;47(12):2696-700
pubmed: 2278285
J Cheminform. 2015 May 30;7:23
pubmed: 26136848
Drug Inf J. 1975 May-Sep;9(2-3):239-40
pubmed: 10236978
Molecules. 2014 Jul 24;19(8):10755-802
pubmed: 25061724