Critical Analysis of Drug Product Recalls due to Nitrosamine Impurities.

Carcinogens / analysis Drug Contamination / prevention & control Drug Industry Drug Recalls Humans Nitrosamines / analysis Pharmaceutical Preparations / chemistry United States United States Food and Drug Administration

Journal

Journal of medicinal chemistry
ISSN: 1520-4804
Titre abrégé: J Med Chem
Pays: United States
ID NLM: 9716531

Informations de publication

Date de publication:
25 03 2021
Historique:
pubmed: 13 3 2021
medline: 5 6 2021
entrez: 12 3 2021
Statut: ppublish

Résumé

A product recall is the outcome of a careful pharmacovigilance; and it is an integral part of drug regulation. Among various reasons for product recall, the detection of unacceptable levels of carcinogenic impurities is one of the most serious concerns. The genotoxic and carcinogenic potential of

Identifiants

DOI: 10.1021/acs.jmedchem.0c02120 PMID: 33706513
pubmed: 33706513
doi: 10.1021/acs.jmedchem.0c02120
doi:

Substances chimiques

Carcinogens 0
Nitrosamines 0
Pharmaceutical Preparations 0

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

2923-2936

Auteurs

Sonali S Bharate (SS)

Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management, SVKM's NMIMS, V.L. Mehta Road, Vile Parle (W), Mumbai 400056, India.
ORCID: 0000-0001-7267-5080

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Classifications MeSH

questionsmedicales.fr › Actions chimiques et utilisations › Actions toxiques › Noxas › Cancérogènes › Critical Analysis of Drug Product Recalls due...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Contamination de médicament › Critical Analysis of Drug Product Recalls due...
questionsmedicales.fr › Technologie, industrie et agriculture › Industrie › Secteur secondaire › Industrie pharmaceutique › Critical Analysis of Drug Product Recalls due...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Sécurité des produits de consommation › Rappels et retraits de produits › Rappels de médicaments › Critical Analysis of Drug Product Recalls due...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Critical Analysis of Drug Product Recalls due...
questionsmedicales.fr › Composés chimiques organiques › Composés nitrosés › Nitrosamines › Critical Analysis of Drug Product Recalls due...
questionsmedicales.fr › Préparations pharmaceutiques › Critical Analysis of Drug Product Recalls due...
questionsmedicales.fr › Régions géographiques › Amériques › Amérique du Nord › États-Unis › Critical Analysis of Drug Product Recalls due...
questionsmedicales.fr › Organisations et économie des soins de santé › Organismes › Gouvernement › Agences gouvernementale américaines › Department of Health and Human Services (USA) › Public Health Service (USA) › Food and Drug Administration (USA) › Critical Analysis of Drug Product Recalls due...