HS-GC-FID method for quantification of HFA-152a in cell culture media, and plasma from a range of species and regulatory compliant validations [0.03%]
一种量化细胞培养基和多种动物血浆中HFA-152a的HS-GC-FID方法及符合法规要求的方法学验证
Philip J Kuehl,Stuart Corr,Jabari Farrar et al.
Philip J Kuehl et al.
Introduction: 1,1-Difluoroethane (HFA-152a) is being developed as an alternative propellant in pressurized metered dose inhalers (pMDIs). As a part of the regulatory development pathway, pharmacology, toxicology and clini...
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 [0.03%]
非啮齿类动物的心血管遥测研究的技术指导原则：为ICH E14/S7B问答提供高质量的QTc数据
Eric I Rossman,Todd A Wisialowski,Hugo M Vargas et al.
Eric I Rossman et al.
The ICH E14/S7B Questions and Answers (Q&As) guideline introduces the concept of a "double negative" nonclinical scenario (negative hERG assay and negative in vivo QTc study) to demonstrate that a drug does not produce a clinically relevant...
"Appraisal of state-of-the-art" The 2021 Distinguished Service Award of the Safety Pharmacology Society: Reflecting on the past to tackle challenges ahead [0.03%]
面向未来攻克难关之安全药理学会2021年度杰出服务奖“评估最新进展”
Jean-Pierre Valentin,Alicia Sibony,Marie-Luce Rosseels et al.
Jean-Pierre Valentin et al.
This appraisal of state-of-the-art manuscript highlights and expands upon the thoughts conveyed in the lecture of Dr. Jean-Pierre Valentin, recipient of the 2021 Distinguished Service Award of the Safety Pharmacology Society, given on the 2...
Simultaneous assessment of central nervous and respiratory systems using jacketed telemetry in socially-housed rats: Application of the "3Rs" principles in core battery safety pharmacology studies [0.03%]
结合使用背负式遥测装置同时评价大群体实验鼠的中枢和呼吸系统的药理安全性：在核心安全药理学研究中应用“3R”原则
Raafat Fares,Pascal Champéroux
Raafat Fares
Central nervous (CNS) and respiratory systems are routinely investigated in safety pharmacology core battery studies. For small molecules, the assessment of both vital organ systems is frequently done in rats in two distinct studies. With t...
Improving the in Vivo QTc assay: The value of implementing best practices to support an integrated nonclinical-clinical QTc risk assessment and TQT substitute [0.03%]
改善在 vivo QTc 考验：实施最佳规范支持整合的非临床 - 临床 QTc 风险评估和 TQT 替代试验的价值
Hugo M Vargas,Eric I Rossman,Todd A Wisialowski et al.
Hugo M Vargas et al.
Recent updates and modifications to the clinical ICH E14 and nonclinical ICH S7B guidelines, which both relate to the evaluation of drug-induced delayed repolarization risk, provide an opportunity for nonclinical in vivo electrocardiographi...
The impact of environmental and biological factors on the resting heart rate of dogs as assessed using 20 years of data from safety pharmacology studies [0.03%]
基于安全药理学研究的20年数据评估环境和生物学因素对犬只静息心率的影响
Elham Ataei Alizadeh,Thomas Trautmann,Florian Krause et al.
Elham Ataei Alizadeh et al.
Introduction: A safety pharmacology study detects and evaluates potential side effects of a new drug on physiological function at therapeutic levels and above and, in most cases, prior to the initiation of clinical trials...
The incidence of spontaneous arrhythmias in telemetered beagle dogs, Göttingen Minipigs and Cynomolgus non-human primates: A HESI consortium retrospective analysis [0.03%]
自发性心律失常在遥测比格犬、哥廷根迷你猪和食蟹猴中的发生率：HESI联盟回顾性分析
Emmanuel Boulay,Loïs S Miraucourt,Michael K Pugsley et al.
Emmanuel Boulay et al.
Introduction: Characterization of the incidence of spontaneous arrhythmias to identify possible drug-related effects is often an important part of the analysis in safety pharmacology studies using telemetry. ...
Sensitive and rapid method for the quantitation of amoxicillin in minipig plasma and milk by LC-MS/MS: A contribution from the IMI ConcePTION project [0.03%]
一种敏感且快速的定量方法：在IMI ConcePTION项目中用于小猪血浆和乳汁中的氨苄西林定量的LC-MS/MS法
Yeghig Armoudjian,Qi Lin,Bart Lammens et al.
Yeghig Armoudjian et al.
The IMI project ConcePTION was launched to fill the knowledge gap of using medicines during pregnancy and lactation. To achieve this goal, several studies are being conducted, including the bioanalysis of amoxicillin in minipig plasma and m...
Validation of an LC-MS/MS method for quantitation of fostemsavir in plasma [0.03%]
用于测定血浆中福斯曲普坦浓度的LC-MS/MS方法的验证
Siddhartha Lolla,Kumar Shiva Gubbiyappa,Shankar Cheruku et al.
Siddhartha Lolla et al.
Background: A novel, sensitive and specific LC-MS/MS technique was developed and validated for the quantification of fostemsavir in human plasma and its pharmacokinetic application in rabbits. ...
Comparison of validity of standard nonclinical group size selection versus standard clinical group sizes for nonhuman primate QTc prolongation evaluation [0.03%]
标准非临床群组规模选择与用于非人灵长类动物QTc延长评估的常规临床规模的选择有效性比较研究
David Holdsworth,Derek D Best,Katarina Haist et al.
David Holdsworth et al.
The number of animals used in a nonhuman primate (NHP) in vivo QTc assessment conducted as part of the safety pharmacology (SP) studies on a potential new drug is relatively small (4-8 subjects). The number is much smaller than the number o...