The Use of Surrogate Matrix for Calibrators in the Analysis of Dried Blood Samples - A Feasibility Study [0.03%]
surrogate matrix校准品在干血斑样本分析中的应用——一项可行性研究
Dong Hun Lee,Iris Xie,Matthew Solomon et al.
Dong Hun Lee et al.
Experiments designed to assess the ability to analyze Volumetric Absorptive Microsampling (VAMS®) or Tasso-M20 dried blood samples using ligand binding assays to support pharmacokinetic studies are described. An internally developed monocl...
TLR7-Adjuvanted Ionizable Lipid Nanoparticles for mRNA Vaccine Delivery [0.03%]
基于TLR7佐剂的可电离脂质纳米颗粒mRNA疫苗递送系统
Bishal Misra,Krystal A Hughes,William H Pentz et al.
Bishal Misra et al.
Ionizable lipid nanoparticles (LNPs) are clinically relevant non-viral vectors that allow intracellular delivery of mRNA vaccines to immune cells. To fight against notorious pathogens and cancer, mRNA vaccines necessitate the addition of an...
Model-Informed Immunogenicity Assessment of Nivolumab as Monotherapy and in Combination with Ipilimumab [0.03%]
纳武利尤单抗作为单一疗法和与伊匹木单抗联合治疗的模型驱动免疫原性评估
Yue Zhao,Li Li,Jessica Ma et al.
Yue Zhao et al.
Immunogenicity to biotherapeutics can lead to antidrug antibodies (ADAs) that have potential to alter pharmacokinetics (PK), efficacy, and safety. Here we provide an extensive model-informed immunogenicity assessments of nivolumab monothera...
Realistic Albumin Concentrations in Virtual Subjects Across A Spectrum of Renal Function to Account for Variability in Protein Binding Within PBPK Models [0.03%]
在具有不同程度肾功能的虚拟受试者中采用接近真实浓度的白蛋白以解释结合蛋白结合力在PBPK模型中的差异性变异
Yuming Hu,Daniel Scotcher
Yuming Hu
Use of physiologically-based pharmacokinetic (PBPK) modelling for extrapolation to organ impairment populations requires successful prediction for physiological changes. For drugs bound to human serum albumin (HSA), prediction of albumin co...
IFN-γ/IL-2 Double-Color FluoroSpot Assay for Monitoring Human Primary T Cell Activation: Validation, Inter-Laboratory Comparison, and Recommendations for Clinical Studies [0.03%]
人初级T细胞活化的监测：干扰素-γ/白介素-2双色荧光斑点实验的验证、实验室间的比较及临床研究中的应用建议
Alexandra Mauthe,Edward Cedrone,Raquel Villar-Hernández et al.
Alexandra Mauthe et al.
The enzyme-linked immunosorbent spot (EliSpot) assay and its fluorescence-based version, FluoroSpot, are sensitive immunoassays commonly used to quantify antigen-specific T and B lymphocytes and other immune cells in peripheral blood or hom...
Comparative Study
The AAPS journal. 2025 Apr 25;27(4):81. DOI:10.1208/s12248-025-01072-3 2025
Physiologically Based Modeling of Cefoxitin, Cefazolin, and Piperacillin Pharmacokinetics in Obese and Lean Rats [0.03%]
基于生理的cefoxitin、cefazolin和piperacillin在肥胖大鼠和正常体重大鼠体内药动学建模研究
Yi-Hua Sheng,Katarzyna Kosicka-Noworzyń,Anna Siemiątkowska et al.
Yi-Hua Sheng et al.
The prevalence of obesity is rapidly increasing worldwide, however there is a notable gap in understanding how obesity affects the pharmacokinetics of drugs and how dosing should be adjusted in obese population. The goals of this work were ...
Assessing the Impact of Multiple Imputation Algorithms on Pharmacokinetic Model Performance: A Simulation-Based Study [0.03%]
基于模拟的多重插补算法对药代动力学模型性能影响评估研究
Thomas Duflot,Lucie Fayette,Céline Konecki et al.
Thomas Duflot et al.
This study compared multiple imputation (MI) algorithms in a one-compartment pharmacokinetic (PK) scenario with oral absorption. Four covariates (two continuous, two dichotomous) linked to PK parameters were randomly removed under a missing...
Alexander Pöhler,Uwe Wessels,Roland F Staack et al.
Alexander Pöhler et al.
IgM-selective proteolytic cleavage can become a groundbreaking tool for immunoassay-based bioanalysis. We tested the utility of a newly introduced IgM-selective protease in three different bioanalytical applications and showed that protease...
Thy Follmer,Seth Clark,Thorsten Verch
Thy Follmer
Complex assays such as immunoassays can be affected by robustness and ruggedness factors. Associated risks can be reduced by a systematic performance assessment across key factors followed by control strategies. However, the large number of...
Survey and Establishment of Points to Consider for Application of Analytical Techniques to Evaluate Protein Aggregates and Insoluble Particles in Biopharmaceuticals: Experiences in Japan Biopharmaceutical Consortium [0.03%]
生物制品中蛋白质聚集体和不可溶微粒分析方法适用性的考量因素的调研及确定：日本生物制药联盟的经验
Hiroko Shibata,Satoshi Saitoh,Masato Kiyoshi et al.
Hiroko Shibata et al.
Protein aggregates and insoluble particles in biopharmaceutical products are impurities that can elicit immunogenicity. The protein aggregates and insoluble particles form during manufacturing and storage, and should be characterized to opt...