A range of generic valsartan products have been found to be contaminated with nitrosamines (principally N-nitrosodimethylamine; NDMA). We present information and discuss various elements of this phenomenon including: actions taken by regulatory agencies, source of the nitrosamine impurities, range of possible risk assessments based mainly on ICH M7 criteria, epidemiological assessment and analytical aspects.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1016/j.yrtph.2019.01.007 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Value of Label-Free Ubiquitin-Proteomic Analysis on Defining the Protective Mechanism of Valsartan against Doxorubicin-Induced Heart Failure.
Curr Cancer Drug Targets
January 2025
Department of Cardiology, Affiliated Zhongshan Hospital of Dalian University, Dalian 116001, Liaoning, China.
Introduction: The cardiotoxicity and subsequent Heart Failure (HF) induced by Doxorubicin (DOX) limit the clinical application of DOX. Valsartan (Val) is an angiotensin II receptor blocker that could attenuate the HF induced by DOX. However, the underlying mechanism of Val in this process is not fully understood.
View Article and Find Full Text PDFComparison of the effect of Sacubitril/Valsartan with Losartan and Captopril in improving right ventricular function in patients with right heart failure, a randomized clinical controlled trial.
J Prev Med Hyg
September 2024
Department of Cardiology, School of Medicine, Health Management and Economics Research Center, Hazrat-e Rasool General Hospital, Iran University of Medical Sciences, Tehran, Iran.
Background: There is evidence supporting the efficacy of Sacubitril /Valsartan for improving left heart failure, but few studies have examined its effects on right ventricular (RV) dysfunction. The current study aimed to investigate the effects of Sacubitril /Valsartan on RV dysfunction in patients with right heart failure.
Methods: The current study was a randomized and parallel clinical trial study.
JiangyaTongluo decoction ameliorates tubulointerstitial fibrosis via regulating the SIRT1/PGC-1α/mitophagy axis in hypertensive nephropathy.
Front Pharmacol
December 2024
Dongfang Hospital, Beijing University of Chinese Medicine, Beijing, China.
Introduction: With the increasing prevalence of hypertension, the incidence of kidney diseases is also increasing, resulting in a serious public burden. Jiangya Tongluo decoction (JYTL), a recognized prescription in traditional Chinese medicine (TCM), is commonly used to calm an overactive liver and reduce excess yang, while also promoting blood flow to alleviate obstructions in the meridians. Previous research has indicated that JYTL may help mitigate kidney damage caused by hypertension; however, the underlying mechanisms have not been thoroughly assessed.
View Article and Find Full Text PDFRemoval efficiencies and environmental risk assessment of selected pharmaceuticals and metabolites at a wastewater treatment plant in Pietermaritzburg, South Africa.
Environ Monit Assess
December 2024
School of Chemistry and Physics, University of KwaZulu-Natal, Westville Campus, Durban, 4000, South Africa.
This research study critically evaluates the concentrations of selected pharmaceuticals found within wastewater and at various stages within a selected wastewater treatment plant. The study further investigates the effects of seasonal variation, between wet and dry months, on the removal of target analytes. To the best of the authors' knowledge, ivermectin in wastewater has not been investigated in South Africa.
View Article and Find Full Text PDFDevelopment of silver-doped carbon dots sensor derived from lignin for dual-mode fluorometric and spectrophotometric determination of valsartan in a bulk powder and a commercial product.
Heliyon
December 2024
Department of Chemistry, College of Science, King Saud University, P.O. Box 22452, Riyadh 11495, Saudi Arabia.
Doping of carbon dots (CDs) with heteroatoms has garnered growing attention in recent years as a useful method of controlling their physicochemical properties. In this study, a new dual-mode sensor based on silver-doped CDs (AgCDs) derived from lignin was developed for fluorometric and spectrophotometric determination of valsartan (VAL). The analysis of AgCDs revealed a structure that closely resembled graphene oxide, with the successful doping of Ag.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!