Concentration response analyses for QT data with several active compounds [0.03%]
多种有效成分的QT数据浓度-反应关系分析
Günter Heimann,Giulia Lestini,Jochen Zisowsky
Günter Heimann
PK-QTc analyses are routinely done as part of most drug development programs. Usually, the PK concentration of a single compound is related to the QTc effect. However, in many instances there are several active compounds, for example a pare...
Risks encountered when not adjusting for diurnal variation and food effect in QTcF analysis based on phase I data [0.03%]
基于I期数据进行QTcF分析时未校正日间变异性和食物效应所遇到的风险
Maddlie Bardol,Andrea Henrich,Celine Sarr et al.
Maddlie Bardol et al.
Phase I single and multiple ascending dose studies are more and more often used to evaluate QT liability of new drugs. However, these studies are not primarily tailored to concentration-QT analysis and to control or document influential fac...
Correction to: An automated pipeline to generate initial estimates for population Pharmacokinetic base models [0.03%]
Correction to: 自动化生成人群药代动力学初始模型的流程
Zhonghui Huang,Matthew Fidler,Minshi Lan et al.
Zhonghui Huang et al.
Catalyzing change in MID3 through globalization, education, and innovation [0.03%]
通过全球化、教育和创新引发MID3变革
Douglas W Chung,Sihem Ait-Oudhia,Doug Chung
Douglas W Chung
The landscape of pharmaceutical research and drug development is undergoing a significant evolution, with Model-Informed Drug Discovery and Development (MID3) as a transformative approach to accelerate innovation. Realizing the full potenti...
Aggregate data modelling: A fast implementation for fitting pharmacometrics models to summary-level data in R [0.03%]
基于汇总数据的群体药代动力学模型的高效实现方法研究
Hidde van de Beek,Pyry A J Välitalo,J G Coen van Hasselt et al.
Hidde van de Beek et al.
Pharmacometric modelling is traditionally performed using individual level data. Recently a new method was developed to fit pharmacometric models to summary level - or aggregate - data. This methodology allows for jointly modelling differen...
Identification and characterization of virtual sub-populations through phenotype-guided filtering. The challenging case of nonidentifiable models in the context of therapeutic evaluation [0.03%]
基于表型引导筛选的虚拟亚群的识别与特征分析。治疗效果评价中不可识模型面临的挑战案例分析
Didier Zugaj,Fahima Nekka
Didier Zugaj
The usefulness of mathematical modeling of biological systems and their responses to exogenous products is now well recognized. However, this recognition is marred by problems of unreliability of representations of real populations and pred...
On the coupling between a basic FcRn mechanism and target-mediated disposition of antibodies [0.03%]
FcRn基础机制与抗体靶向介导消除之间的关系研究
Csaba B Kátai,Manon M M Berns,Jeroen Elassaiss-Schaap
Csaba B Kátai
Understanding the pharmacokinetics of therapeutic antibodies often requires a detailed investigation of the mechanisms governing their distribution and clearance. Two of the most important mechanisms are the salvage and recycling of antibod...
A note on phase I interleaved versus parallel group ascending dose designs for concentration-QTc analyses [0.03%]
关于浓度-QTc分析的升剂量期I交错设计与平行组设计的一点思考
Günter Heimann,Thomas Dumortier,Karin Meiser
Günter Heimann
PK-QTc analyses are an integral part of drug development programs. These analyses are often based on phase I study data, and the question may be asked whether the design of these phase I studies has an impact on the precision of the corresp...
QT interval prolongation: clinical assessment, risk factors and quantitative pharmacological considerations [0.03%]
心电图QT间期延长：临床评估、风险因素及定量药理学考虑
Verena Gotta,Birgit Donner
Verena Gotta
Prolongation of the QT interval in the ECG is a critical finding that signifies an extended duration from the onset of ventricular depolarization to the end of ventricular repolarization. It can predispose patients to life-threatening arrhy...
An automated pipeline to generate initial estimates for population Pharmacokinetic base models [0.03%]
用于人群药代动力学基础模型的初始估计的自动化流程构建
Zhonghui Huang,Matthew Fidler,Minshi Lan et al.
Zhonghui Huang et al.
Nonlinear mixed-effects models rely on adequate initial parameter estimates for efficient parameter optimization. Poor initial estimates can result in failed model convergence or termination with incorrect parameter estimates. Non-compartme...