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Recommendations from a global cross-company data sharing initiative on the incorporation of recovery phase animals in safety assessment studies to support first-in-human clinical trials

机译：来自全球跨公司数据共享计划的建议，关于将恢复期动物纳入安全性评估研究中以支持首次人体临床试验

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Sewell Fiona; Chapman Kathryn; Baldrick Paul; Brewster David; Broadmeadow Alan; Brown Paul; Burns-Naas Leigh Ann; Clarke Janet; Constan Alex; Couch Jessica; Czupalla Oliver; Danks Andy; DeGeorge Joseph; de Haan Lolke; Hettinger Klaudia; Hill Marilyn; Festag Matthias; Jacobs Abby; Jacobson-Kram David; Kopytek Stephan; Lorenz Helga; Moesgaard Sophia Gry; Moore Emma; Pasanen Markku; Perry Rick; Ragan Ian; Robinson Sally; Schmitt Petra M.; Short Brian; Lima Beatriz Silva; Smith Diane; Sparrow Sue; van Bekkum Yvette; Jones David;
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1. Recommendations from a global cross-company data sharing initiative on the incorporation of recovery phase animals in safety assessment studies to support first-in-human clinical trials [J] . Sewell Fiona, Chapman Kathryn, Baldrick Paul, Regulatory Toxicology and Pharmacology: RTP . 2014,第1期

机译：来自全球跨公司数据共享计划的建议，关于将恢复期动物纳入安全性评估研究中以支持首次人体临床试验
2. Recommendations from a global cross-company data sharing initiative on the incorporation of recovery phase animals in safety assessment studies to support first-in-human clinical trials [J] . Sewell Fiona, Chapman Kathryn, Baldrick Paul, Regulatory Toxicology and Pharmacology: RTP . 2014,第1期

机译：全球跨公司数据共享倡议的建议对安全评估研究中的复苏阶段动物纳入，以支持一中临床试验
3. Global cross-company data-sharing on the use of recovery animals for human safety assessment [J] . Sewell Fiona, Chapman Kathryn Toxicology Letters: An International Journal Providing a Forum for Original and Pertinent Contributions in Toxicology Research . 2014,第Null期

机译：关于使用恢复动物进行人类安全评估的全球跨公司数据共享
4. STEM-32. PRE-CLINICAL SAFETY AND EFFICACY STUDIES OF NEURAL STEM CELL MEDIATED CARBOXYLESTERASE/IRINOTECAN ENZYME/PRODRUG GENE THERAPY FOR RECURRENT GLIOMA LEADING TO FIRST-IN-HUMAN PHASE I CLINICAL TRIAL [O] . Lucy Ghoda, Marianne Metz, Revathiswari Tirughana, 2017

机译：STEM-32。神经干细胞介导的羧化酶/异丁烯酸酶/药物前体基因疗法治疗人脑胶质瘤至临床第一阶段的临床前安全性和有效性研究
5. HIT Poster session 2P479Strain concordance in a real-world setting: experience in our laboratory after equipment upgradeP4803D echocardiography is a fast-learning and reliable method for the measurements of left atrial volumesP481Echocardiographic parameters associated with long-term appropriate antiarrhythmic therapies in cardiac resynchronization therapy defibrillator patientsP482Noninvasively measured global wasted myocardial work allows for quantitative assessment of typical left ventricular mechanical dyssynchrony pattern in patients with left bundle branch blockP483The impact of adherence to physical exercise on the improvement of cardiovascular remodeling and metabolic status in healthy untrained postmenopausal womenP484The impact of the latest chamber quantification recommendations on the prediction of left atrial appendage thrombus presenceP485The cardiac-enriched miRNAs plasma levels (miR-1, miR-133a, miR-499) reflect the impaired left ventricular systolic function and correlate with cardiac necrosis markers in early phase of NSTE-ACSP486Acute regional myocardial deformation changes in patients with severe aortic stenosis and preserved ejection fraction after isolated aortic valve replacementP487Left ventricular rotational deformation in asymptomatic patients with chronic aortic regurgitation and normal left ventricular ejection fraction P488The appropriate use of transthoracic echocardiography for the exclusion of infective endocarditisP489In patients with hypertrophic cardiomyopathy, left ventricular mass and shape by three-dimensional echocardiography are related with dynamic obstruction and functional capacityP490Mitral leaflet sizing in hypertrophic cardiomyopathy: impact of method and timingP491Echocardiographic predictors of atrial fibrillation in obese womenP492Echocardiographic risk factors for 30 day mortality after the hybrid procedure for hypoplastic left heart syndromeP493Left ventricular mass is an independent predictor of coronary flow reserve: insights from a single centre stress echo cohortP494Transesophageal echocardigoraphy uner conscious sedation for guiding cryoballoon pulmonary vein isolation in paroxysmal atrial fibrillation - the safety and feasibility studyP495Transesophageal echocardigoraphy under conscious sedation for guiding cryoballoon pulmonary vein isolation in paroxysmal atrial fibrillation - the safety and feasibility studyP496Three-dimensional trans-esophageal echocardiography assessment of the immediate morphological changes of the mitral annulus after percutaneous mitral edge-to-edge repairP497Clinical value of global and regional longitudinal strain in prediction of myocardial ischemia in asymptomatic diabetes type 2 patientsP499Comparison of prognostic operative risk impact on the global longitudinal strain right ventricle (GLS RV) and tricuspid annular plane systolic excursion (TAPSE) values in patients with ischemic cardioP498Right heart function in early diastolic dysfunction: 2D speckle-tracking echocardiography-based assessment of right atrial and right ventricular functionP500 Comparison of 2D, 3D transesophageal echocardiography and computed tomography during the assessment of left atrial appendage closure [O] . JF. Cueva Recalde, A. Velcea, S. Aguiar Rosa, 2016

机译：HIT墙报2P479Strain一致性在真实世界场景：在设备upgradeP4803D超声心动图检查后，我们实验室的经验是为测量快速学习和可靠的方法左心房在心脏再同步治疗除颤器patientsP482Noninvasively长期适当的抗心律失常治疗相关volumesP481Echocardiographic参数测量了全球浪费心肌工作允许患者依从性左束支传导blockP483The影响到体育锻炼上的最新室定量建议健康未受训练的绝经后womenP484The影响心血管重构和代谢状态的改善典型左室机械不同步模式的定量评估上的预测左心耳血栓presenceP485The心脏富集miRNA的血浆水平（的miR-1，的miR-133a的，的miR-499）反映受损左心室收缩功能及CORREL吃用的患者的严重主动脉瓣狭窄NSTE-ACSP486Acute区域心肌变形的变化早期心肌坏死标志物和后射血分数分离主动脉瓣膜replacementP487Left心室旋转在无症状患者慢性主动脉瓣反流和正常左心室射血分数P488The适当使用不变形对于感染endocarditisP489In肥厚型心肌病患排除经胸超声心动图，由三维超声心动图左心室质量和形状与动态障碍物和功能capacityP490Mitral相关小叶上浆肥厚型心肌病：的心房纤维性颤动中肥胖womenP492Echocardiographic方法和timingP491Echocardiographic预测结果的影响对于syndromeP493Left左室质量发育不全左心脏杂交程序后的30天死亡率的危险因素是冠状动脉血流RESER的独立预测因子已经：见解从一个单一的中心的应力回波cohortP494Transesophageal echocardigoraphy纳清醒镇静用于引导低温球囊肺静脉阵发性心房颤动隔离 - 下清醒镇静的安全性和可行性studyP495Transesophageal echocardigoraphy为阵发性心房颤动引导低温球囊肺静脉隔离 - 安全性和可行性studyP496Three的经皮二尖瓣边缘到边缘repairP497Clinical全球及区域纵向应变的心肌缺血的预测无症状糖尿病类型值2 patientsP499Comparison对预后手术风险冲击二尖瓣环的直接形态学变化维经食道超声心动图评估全球纵向应变右心室（RV GLS）和三尖瓣环平面收缩漂移（TAPSE）患者的早期舒张功能障碍性脑缺血cardioP498Right心脏功能值：2D斑点的trackin右心室2D的functionP500比较右心房的和g超声心动图基于评估，3D食管超声心动图和计算机断层左心耳闭合的评估过程中

Recommendations from a global cross-company data sharing initiative on the incorporation of recovery phase animals in safety assessment studies to support first-in-human clinical trials

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