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...
Comprehensive protocol for culturing and functionally characterizing primary mixed neural cells from the neonatal rat cortex [0.03%]
来自新生大鼠皮层的主要混合神经元的培养和功能表征的全面方案
Thaynan Silva Ramos,Matheus Heidemann Tempone,Hercules Rezende Freitas et al.
Thaynan Silva Ramos et al.
In vitro models using purified neurons or glial cells are crucial for studying neurological functions but often overlook intercellular interactions. Mixed neural cell cultures offer a more physiologically relevant system by preserving cell-...
Therapeutic drug monitoring of busulfan and cyclophosphamide in hematologic malignancies: An LC-MS/MS development, validation and application [0.03%]
用于血液系统恶性肿瘤中巴利昔尤单抗和环磷酰胺治疗药物监测的LC-MS/MS法的开发、验证及应用研究
Jinxingyi Wang,Ruyu Tao,Hanshuai Hu et al.
Jinxingyi Wang et al.
Background: Busulfan and cyclophosphamide (Bu-Cy) is a widely used conditioning regimen for hematopoietic stem cell transplantation (HSCT) in the treatment of hematologic malignancies. To explore the exposure-efficiency r...
Evaluation of the Effects of cypermethrin Toxicity on Liver Mitochondria of Male Albino Rats [0.03%]
评估氯氰聚酯毒性对雄性白鼠肝线粒体的影响
Venkataramanaiah Poli,Srinivasulu Reddy Motireddy
Venkataramanaiah Poli
The purpose of this study is to look into the toxic effects of giving male albino rats cypermethrin (CPM). In order to achieve this, three groups of rats were formed. Every group received the same amount of saline, including the control gro...
Legacy hERG study data in contemporary integrated risk assessments - mitigating the risk of protocol and positive control article differences [0.03%]
经典hERG研究数据在现代综合风险评估中的应用——减轻协议和阳性对照文章差异的风险
Richard W Daniels,James W Kramer,Matthew M Abernathy et al.
Richard W Daniels et al.
Testing new molecules against the hERG potassium channel has been a routine component of secondary pharmacology assessments for more than a quarter of a century. In 2005, the ICH S7B guidance required a GLP hERG study prior to first adminis...
Spatial regulation of CD14-like epitope in hematopoietic and ocular tissues of cultured North Atlantic lumpfish (Cyclopterus lumpus) and spotted wolffish (Anarhichas minor) during bacterial infection and temperature variations [0.03%]
北大西洋团突鱼(Cyclopterus lumpus)和点纹狼鱼(Anarhichas minor)在细菌感染及温度变化时造血组织和眼组织中CD14-like表位的空间调节
Rebecca R Kwabiah,Lauren E Murphy,Hélène Paradis et al.
Rebecca R Kwabiah et al.
The development of new tools for a better understanding of innate immune mediated responses to tissue damage in emerging model organisms could offer novel approaches to inform toxicology, disease mitigation and/or drug discovery. Innate imm...
A retrospective analysis of the concordance between cardiovascular effects in telemetry studies, toxicity studies, and early clinical trials [0.03%]
遥测研究、毒性研究及早期临床试验中心血管影响的一致性回顾分析
Andrea Greiter-Wilke,Jan Attig,Simon Bassett
Andrea Greiter-Wilke
This work aimed to compare the ability of several ECG technologies used in toxicity studies to identify cardiovascular effects. A retrospective analysis of 41 drug development projects across the Roche portfolio from 2005 to 2023 was conduc...