Results from an EFPIA, JPMA, PhRMA industry survey on reopening and revamping the ICH S7A guidance on safety and secondary pharmacology [0.03%]
EFPIA、JPMA和PhRMA关于恢复和重组ICH S7A指南（安全性和继发药理学）的行业调查结果
Jean-Pierre Valentin,Katsuyoshi Chiba,Derek Leishman et al.
Jean-Pierre Valentin et al.
The ICH S7A guideline on safety pharmacology has remained unchanged since its inception in 2000, fulfilling its crucial role in safeguarding clinical trial participants and patients (ICH S7A). However, in the meanwhile there has been signif...
Development and validation of a quantitative UHPLC-HRMS bioanalytical method for equine anti-doping control [0.03%]
赛马反兴奋剂控制的定量UHPLC-HRMS生化分析方法的开发和验证
Wafaa El-Ghaly,Taha El Kamli,Ange Melisse Ariane Gongbe et al.
Wafaa El-Ghaly et al.
The quantification of banned substances in equine antidoping control, especially in racehorse urine, necessitates robust analytical methods with high detection levels due to the extremely low concentrations of the target substances and the ...
Telemetry in toxicology studies - A comparison of data across species, technologies and time [0.03%]
毒理学研究中的遥测技术——跨物种、技术和时间的比较数据
Derek D Best,Matthew M Abernathy,Derek J Leishman
Derek D Best
Telemetry technology allows collection of quantitative cardiovascular safety pharmacology data in repeat dose toxicology studies. The ICH M3(R2) guideline suggests that inclusion of safety pharmacology endpoints into toxicology studies shou...
High-content cell imaging for chemical toxicity screening in the model organism Caenorhabditis elegans [0.03%]
秀丽线虫高内涵细胞成像化学毒性筛选体系研究
Camiryn J Kardal,Spencer R Dmytruk,Abdullah Qureshi et al.
Camiryn J Kardal et al.
The use of animal models for screening environmental chemicals for toxicity is an important step towards determining potential hazards to humans. Due to the large number of environmental chemicals with unknown biological activity, high-thro...
Lipopolysaccharide-induced abdominal nociception model in adult zebrafish (Danio rerio) [0.03%]
腹脂多糖诱导的成年斑马鱼（丹尼罗氏斑马鱼）腹腔疼痛模型
Maria Rayane C de Oliveira,Sacha Aubrey A R Santos,Gabriela A do Nascimento et al.
Maria Rayane C de Oliveira et al.
In this study, a behavioral model of LPS-induced abdominal nociception was developed in adult zebrafish (Danio rerio), aZF. Initially, the toxicity of different LPS concentrations was assessed. The abdominal nociceptive response to the lowe...
Fast urine metabolomics for the assessment of Zopiclone effects on insomnia [0.03%]
快速尿代谢组学评估佐匹克隆对失眠的影响
Jun Li,Yang Zhao,Guifang Liu et al.
Jun Li et al.
Insomnia is a common symptom of many diseases and is closely associated with neurodegenerative diseases. Zopiclone is one of several clinical hypnotics for treating insomnia. However, some patients are sensitive to this drug treatment, wher...
Taking a deep breath: Evidence-based approaches to respiratory safety assessment [0.03%]
深吸一口气：基于证据的呼吸道安全评估方法
J J Kremer,M Bridgland-Taylor,M Clark et al.
J J Kremer et al.
Modernization of the necessity and conduct of nonclinical respiratory assays should be undertaken to enhance their translational impact for clinical outcomes, optimize animal and development costs, and ultimately strengthen regulatory relev...
Michael K Pugsley,Simon Authier,Brett R Winters et al.
Michael K Pugsley et al.
The second salary survey of safety pharmacology professionals was conducted in late 2023. This electronic survey was distributed to all members of the Safety Pharmacology Society (SPS). Survey questions assessed demographic variables, profe...
A comparative study of kidney lithogenic agents in Wistar rats by invasive and noninvasive methods [0.03%]
大鼠泌尿系结石致石物质的有创与无创对比研究
S Sakthikarthikeyan,S Ramesh,P Senthilkumar et al.
S Sakthikarthikeyan et al.
Urolithiasis has been globally reported in humans and animals due to multiple factors. Research on the management and treatment of urolithiasis would benefit if suitable lithogenic agents replicate various degrees of severity as seen in hum...
The statistical and pharmacological sensitivity of nonclinical QTc analysis comparing jacketed telemetry and multilead snapshot recording in the same dogs [0.03%]
夹克式遥测与多导联快照记录在同一犬上的非临床QTc分析的统计和药理敏感性研究
Matthew M Abernathy,Derek D Best,Derek J Leishman
Matthew M Abernathy
Quantitative QTc assessment in toxicology studies can use one of two techniques, either continuous telemetry recording in ambulatory animals or short snapshots of electrocardiograms recorded using multilead electrodes in restrained animals....