Non-clinical cardiovascular safety testing: Current status, gaps and emerging trends [0.03%]
非临床心血管安全性试验:现状、不足与趋势展望
Peter Hoffmann,Michael K Pugsley
Peter Hoffmann
Cardiovascular adverse drug reactions remain a leading cause of drug attrition. They may emerge during non-clinical or clinical development and often remain undetected until post-marketing, prompting increased regulatory focus. Historically...
Corrigendum to 'PolyCheck: A hybrid model for predicting polypharmacy-induced adverse drug reactions in tuberculosis treatment using heterogenous drug-target-ADR networks' [Journal of pharmacological and toxicological methods 136 (2025) 108393] [0.03%]
“PolyCheck:一种使用异构药物-靶点-ADR网络预测结核病治疗中多药相互作用引起的不良反应的混合模型”的勘误表
Ahmad Tamim Ghafari,Yuslina Zakaria,Mizaton Hazizul Hasan et al.
Ahmad Tamim Ghafari et al.
A novel, flexible, and accessible method for the ex vivo induction and quantification of excitotoxicity [0.03%]
一种新颖、灵活且易于使用的体外诱导和量化兴奋毒性方法
Samantha J Carew,Christiana M Kennedy,Meghan L Greenland et al.
Samantha J Carew et al.
Excitotoxicity is a key driver of neuronal death in diverse brain conditions, yet most toxicity assays rely on in vitro models that remove cells from their complex native environment within the brain parenchyma. Here, we present a novel ex ...
LC-MS/MS-based simultaneous quantification of chlorthalidone and cilnidipine in rat plasma: Pharmacokinetic evaluation, green analytical assessment, and DoE-driven optimization [0.03%]
基于LC-MS/MS的定量分析氯噻酮和尼群地平在大鼠血浆中的药动学评估、绿色分析评估和DoE驱动优化
Sravanthi Gandu,Kumaraswamy Gandla,Lalitha Repudi
Sravanthi Gandu
A highly sensitive and reproducible liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was systematically developed and optimized using a Quality by Design (QbD) framework for the simultaneous quantification of chlorthalidone ...
Optimization strategy for modeling sick sinus syndrome in rats: Balancing effect and animal care [0.03%]
一种优化的大鼠病态窦房结综合征建模策略:在疗效和动物护理之间求平衡
Liming He,Xinxin Shi,Yucheng Wang et al.
Liming He et al.
Objective: This study aimed to validate the feasibility of establishing a sick sinus syndrome (SSS) rat model by injecting 3 % sodium hydroxide (NaOH) into the jugular vein at a rate of 0.01 mL/s, and to assess reductions...
Corrigendum to "Best practice considerations for nonclinical in vivo cardiovascular telemetry studies in non-rodent species: Delivering high quality QTc data to support ICH E14/S7B Q&As" [J. Pharmacol. Toxicol. Methods 123 (2023) 107270] [0.03%]
关于“非啮齿类动物品种中用于ICH E14/S7B Q&As的非临床在体心血管遥测研究的最佳实践考虑:提供高质量的QTc数据”(J. Pharmacol. Toxicol. Methods 123 (2023) 107270)的勘误表
Eric I Rossman,Todd A Wisialowski,Hugo M Vargas et al.
Eric I Rossman et al.
Exploratory safety investigations in normal, freely moving Göttingen Minipigs using telemetry: Pharmacological validation [0.03%]
利用遥测技术在正常自由活动的哥廷根迷你猪中进行探索性安全调查:药理学验证
Julie Jacobsen,Berit Ø Christoffersen
Julie Jacobsen
Introduction: Adverse cardiovascular (CV) effects is a major cause of drug attrition. Early assessment of CV risk for new drug candidates may be warranted for early de-risking of the further development. Predictive animal...
Introducing the Sinclair Nanopig™ model: Preliminary genomic, proteomic, and hepatic CYP450 characterization for (bio)pharmaceutical safety assessment [0.03%]
一种新型啮齿类动物模型Sinclair Nanopig™的初步基因组学、蛋白质组学及肝脏CYP450表征:药物安全性评价
Yafei Chen,Nathan Bivens,Hong An et al.
Yafei Chen et al.
The Nanopig™ model is an emerging non-rodent platform for (bio)pharmaceutical safety assessment, with potential advantages for translational research. Here, we report initial characterization results using whole genome sequencing (WGS) and...
PolyCheck: A hybrid model for predicting polypharmacy-induced adverse drug reactions in tuberculosis treatment using heterogenous drug-target-ADR networks [0.03%]
基于异构药物-靶点-不良反应网络的抗结核病药物相互作用所致不良反应预测模型
Ahmad Tamim Ghafari,Yuslina Zakaria,Mizaton Hazizul Hasan et al.
Ahmad Tamim Ghafari et al.
Polypharmacy during tuberculosis (TB) treatment, particularly in patients with comorbidities such as diabetes mellitus (DM), significantly increases the risk of adverse drug reactions (ADRs) due to complex drug-drug interactions (DDIs). Exi...
Safety pharmacology: Achieving a quarter century milestone as a scientific discipline [0.03%]
安全药理学:作为科学学科实现四分之一世纪的里程碑
Michael K Pugsley,Brett R Winters,Stephen D Tichenor et al.
Michael K Pugsley et al.
This editorial prefaces the annual themed issue on those methods with application to safety pharmacology (SP) in the Journal of Pharmacological and Toxicological Methods (JPTM). Highlighted content is derived from the 2024 Safety Pharmacolo...