Blood microsampling in cynomolgus monkey and evaluation of plasma PK parameters in comparison to conventional sampling [0.03%]
食蟹猴毛细血管采血及与传统采血的药代动力学参数比较评价研究报告
Simone Bertani,Alberto Donadi,Jessica Franchi et al.
Simone Bertani et al.
Microsampling, a reduced volume sampling method, has successfully gained attention at the International Conference on Harmonization (ICH) level and established benefits support its use in Toxicokinetic (TK) studies. These improved sampling ...
Common chemistry, manufacturing, and control deficiencies in abbreviated new drug applications assessed by the US Food and drug administration: Hurdle to access cost-effective medicines [0.03%]
美国食品药品监督管理机构评估的简化新药申请中的常见化学、生产和控制缺陷及其对低成本药物获取的影响
Samruddhi B Kulkarni,Vinod L Gaikwad
Samruddhi B Kulkarni
To market a generic product in the United States, it must be registered in Common Technical Document (CTD) format with the US Food and Drug Administration. The Generic Drug User Fee Act went into force in 2012, to expedite the timely review...
hERG agonists pose challenges to web-based machine learning methods for prediction of drug-hERG channel interaction [0.03%]
面向药物-心脏钾离子电流调节基因hERG通道相互作用预测的网络机器学习方法面临的挑战研究
Aziza El Harchi,Jules C Hancox
Aziza El Harchi
Pharmacological blockade of the IKr channel (hERG) by diverse drugs in clinical use is associated with the Long QT Syndrome that can lead to life threatening arrhythmia. Various computational tools including machine learning models (MLM) fo...
Overview of the bioanalytical methods used for the determination of benzodiazepines in biological samples and their suitability for emergency toxicological analysis [0.03%]
生物样本中苯二氮卓类药物分析方法的概述及其在急诊毒物检测中的适用性
Mohamed Yafout,Rachid Aït Mouss,Houda Bouchafra et al.
Mohamed Yafout et al.
Benzodiazepines are one of the most widely used classes of drugs around the world. They are medically used in different therapeutic areas including insomnia, anxiety, epilepsy, and anesthesia. Unfortunately, these drugs are very widespread ...
Species comparison of compounds with known blood pressure effects in a vascular smooth muscle cell collagen contraction assay [0.03%]
血管平滑肌细胞胶原收缩试验中的降压化合物种间对比研究
Jessica Treadway,Aimee Bielinski,Mark Zafiratos et al.
Jessica Treadway et al.
Introduction: There is a great need for new approaches early in drug discovery that have the potential to improve clinical translation of compound-mediated cardiovascular effects. Current approaches frequently rely on in ...
Enhancing the functional maturity of hiPSC-derived cardiomyocytes to assess inotropic compounds [0.03%]
利用 hiPSC 分化的心肌细胞增强强心剂化合物的评估功效成熟度
Xiaoyu Zhang,Praful Aggarwal,Ulrich Broeckel et al.
Xiaoyu Zhang et al.
Human induced pluripotent stem cell-derived cardiomyocytes (hiPSC-CMs) present an attractive in vitro platform to model safety and toxicity assessments-notably screening pro-arrhythmic compounds. The utility of the platform is stymied by a ...
Comparative assessment of Ca2+ oscillations in 2- and 3-dimensional hiPSC derived and isolated cortical neuronal networks [0.03%]
基于hiPSC的和分离的二维及三维皮层神经元网络中Ca2+振荡的比较评估
John P Imredy,Gautier Roussignol,Holly Clouse et al.
John P Imredy et al.
Human induced Pluripotent Stem Cell (hiPSC) derived neural cells offer great potential for modelling neurological diseases and toxicities and have found application in drug discovery and toxicology. As part of the European Innovative Medici...
Evaluation of three different 99mTc-based mock-venom agents for lymphoscintigraphy studies in preclinical models of peripheral snakebite envenomation [0.03%]
三种不同的99mTc-Based假毒剂在蛇咬外毒素周围淋巴示踪预临床模型中的评估研究
Nidhi Tiwari,Abhinav Jaimini,Gaurav Kumar Jain et al.
Nidhi Tiwari et al.
Snakebite envenomation is one of the major public health concerns across many countries; with the WHO designating it as a 'priority neglected tropical disease' and stressing for a need to develop novel therapeutic strategies to reduce death...
Assessment of sarcomere shortening and calcium transient in primary human and dog ventricular myocytes [0.03%]
原代培养的人和犬心室肌细胞肌小节缩短及胞内钙瞬变的检测方法
BaoXi Gao,Najah Abi-Gerges,Ky Truong et al.
BaoXi Gao et al.
Understanding translation from preclinical observations to clinical findings is important for evaluating the efficacy and safety of novel compounds. Of relevance to cardiac safety is profiling drug effects on cardiomyocyte (CM) sarcomere sh...
Thirty years of telemetry-based data acquisition for cardiovascular drug safety evaluation: Applications and optimization [0.03%]
基于遥测的三十年心血管药物安全性评价数据获取：应用和优化
Elham Ataei Alizadeh,Karin Graf,Jessica Schiwon et al.
Elham Ataei Alizadeh et al.
Conducting safety evaluations of new drugs using conscious animals has been a specialty of our working group for thirty years. In this article, we review the various technical challenges and solutions dealt with over the years to improve bo...