Overview of global regulatory toxicology requirements for vaccines and adjuvants [0.03%]
全球针对疫苗和佐剂的监管毒理学要求综述
Yuansheng Sun,Marion Gruber,Mineo Matsumoto
Yuansheng Sun
This paper provides an overview of the legislations and regulatory approaches currently applied to the nonclinical safety assessment of human preventive vaccine products in three ICH regions, i.e., the EU, USA, and Japan. Perspectives of th...
Cardiac tissue slices with prolonged survival for in vitro drug safety screening [0.03%]
具有延长存活率的 cardiac 组织切片用于体外药物安全性筛选
Alexandra Bussek,Matthias Schmidt,Jessica Bauriedl et al.
Alexandra Bussek et al.
Introduction: We have recently introduced the use of mammalian cardiac tissue slices for in vitro drug testing purposes. Here we show how this method can be applied for long-term studies in safety pharmacology. ...
Paul Barrow
Paul Barrow
The majority of new preventative and therapeutic vaccines are now assessed for developmental toxicity according to guidelines issued by the FDA in 2006. Despite the absence of confirmed effects in humans, vaccines are frequently suspected o...
Assessment of the effects of changes in body temperature on cardiac electrophysiology in anaesthetised guinea pigs [0.03%]
评估体温变化对麻醉 Guinea 猪心脏电生理的影响
Jens Kågström,Eva-Lena Laumola,Niklas Poijes et al.
Jens Kågström et al.
Introduction: Anaesthetised guinea pigs are commonly used within Safety Pharmacology to evaluate drug effects on cardiac electrophysiology. However, anesthesia compromises the ability to thermoregulate, which can be furth...
Detection of biologically active botulinum neurotoxin--A in serum using high-throughput FRET-assay [0.03%]
采用高通量FRET法检测血清中的肉毒神经毒素-A生物活性
Suresh G Joshi
Suresh G Joshi
Introduction: The goals of this project were to compare fluorescent resonance energy transfer (FRET) assays using a customized FRET substrate (substrate-substrate-A, SSA) with a commercially available FRET substrate (SNAP...
Evaluation of dry blood spot technique for quantification of an Anti-CD20 monoclonal antibody drug in human blood samples [0.03%]
评价干血点技术定量人血样中抗CD20单克隆抗体药物的评估
Yong-Qing Lin,Yilu Zhang,Connie Li et al.
Yong-Qing Lin et al.
Introduction: To evaluate the dried blood spot (DBS) technique in ELISA quantification of larger biomolecular drugs, an anti-CD20 monoclonal antibody drug was used as an example. A method for the quantification of the ant...
Standardization of an ex vivo method for determination of intestinal permeability of drugs using everted rat intestine apparatus [0.03%]
采用回肠翻转法体外测定药物肠道通透性的标准化方法
Pankaj Dixit,Dinesh Kumar Jain,Jacky Dumbwani
Pankaj Dixit
Introduction: Everted gut sac of rat intestine is a paradigm widely employed for determination of absorption kinetics of drugs along with evaluation of effects of absorption enhancers. Since its inception in 1954, it has ...
A coupled experimental and computational approach to quantify deleterious hemodynamics, vascular alterations, and mechanisms of long-term morbidity in response to aortic coarctation [0.03%]
结合实验和计算的耦合方法量化主动脉狭窄反应的有害血流动力学、血管改变和长期发病机制
Arjun Menon,David C Wendell,Hongfeng Wang et al.
Arjun Menon et al.
Introduction: Coarctation of the aorta (CoA) is associated with morbidity despite treatment. Although mechanisms remain elusive, abnormal hemodynamics and vascular biomechanics are implicated. We present a novel approach ...
Establishment of a novel objective and quantitative method to assess pain-related behavior in monosodium iodoacetate-induced osteoarthritis in rat knee [0.03%]
建立客观定量评价单钠碘乙酸诱导的膝关节骨性关节炎疼痛行为的新方法
Hiroyuki Nagase,Seiichiro Kumakura,Kohei Shimada
Hiroyuki Nagase
Introduction: Pain in osteoarthritis (OA) patients can be present at rest but typically worsens with movement of the affected joint. However, useful assessment methods of movement-induced pain in animal models are limited...
Comparison of whole body and head out plethysmography using respiratory stimulant and depressant in conscious rats [0.03%]
比较清醒大鼠全身和头部露出的plethysmography使用的呼吸兴奋剂和抑制剂
Ramakrishna Nirogi,Dhanalakshmi Shanmuganathan,Pradeep Jayarajan et al.
Ramakrishna Nirogi et al.
Introduction: Assessment of respiratory safety is one of the most important requirements for new chemical entity (ICH Guideline S7A). The aim of the present study was to compare and validate respiratory safety pharmacolog...