NDSRIs Crisis in Pharmaceuticals; Insights on Formation Pathways, Root Causes, Risk Management, and Novel Analytical Techniques.

The discovery of a new class of nitrosamine impurities called N-nitroso drug substance related impurities (NDSRIs) in pharmaceuticals has emerged as a significant challenge for the pharmaceutical sector due to their significant genotoxic and mutagenic effects. Regulatory bodies globally in active collaboration with all the concerned stake holders, are taking effective measures to prevent and control NDSRIs. This comprehensive review on NDSRIs discusses formation pathways, root cause analysis, acceptable intake limits, case studies, control strategies and regulatory responses pertaining to recent NDSRI incidents.

Corrigendum to "Nitrosamines crisis in pharmaceuticals - Insights on toxicological implications, root causes and risk assessment: A systematic review" [J. Pharm. Anal. 14 (2024) 100919].

[This corrects the article DOI: 10.1016/j.jpha.

Nitrosamines crisis in pharmaceuticals - Insights on toxicological implications, root causes and risk assessment: A systematic review.

The presence of -nitroso compounds, particularly -nitrosamines, in pharmaceutical products has raised global safety concerns due to their significant genotoxic and mutagenic effects. This systematic review investigates their toxicity in active pharmaceutical ingredients (APIs), drug products, and pharmaceutical excipients, along with novel analytical strategies for detection, root cause analysis, reformulation strategies, and regulatory guidelines for nitrosamines. This review emphasizes the molecular toxicity of -nitroso compounds, focusing on genotoxic, mutagenic, carcinogenic, and other physiological effects.

Updated Intrinsic Role of Phytochemicals against Glyphosate-induced Neurotoxicity: Systematic Review.

Background: Glyphosate-based herbicide (GBH) formulations are organophosphorus pesticides implicated for agricultural use. Several epidemiological reports have reported that the occupational exposure of farmers to glyphosate can cause age-related neurodegeneration.

Objective: the objective of this study is to examine the neurotoxic effects of glyphosate and its intricate role in triggering several neurodegenerative diseases like dementia, nootropic defects, Parkinson's disease, and neurological teratogenic effects due to its negative effects on the nervous system.

Combinatorial Implications of Nrf2 Inhibitors with FN3K Inhibitor: Breast Cancer Study.

Background: Platinum derivatives are chemotherapeutic agents preferred for the treatment of cancers including breast cancer. Oxaliplatin is an anticancer drug that is in phase II studies to treat metastatic breast cancer. However, its usage is constrained by chemoresistance and dose-related side effects.

Updated Clinical Perspectives and Challenges of Chimeric Antigen Receptor-T Cell Therapy in Colorectal Cancer and Invasive Breast Cancer.

In recent years, the incidence of colorectal cancer (CRC) and breast cancer (BC) has increased worldwide and caused a higher mortality rate due to the lack of selective anti-tumor therapies. Current chemotherapies and surgical interventions are significantly preferred modalities to treat CRC or BC in advanced stages but the prognosis for patients with advanced CRC and BC remains dismal. The immunotherapy technique of chimeric antigen receptor (CAR)-T cells has resulted in significant clinical outcomes when treating hematologic malignancies.

An Overview of CDK Enzyme Inhibitors in Cancer Therapy.

The ability to address the cell cycle in cancer therapy brings up new medication development possibilities. Cyclin-dependent kinases are a group of proteins that control the progression of the cell cycle. The CDK/cyclin complexes are activated when specific CDK sites are phosphorylated.