Patient-Centric Drug Product Quality Specifications: a Convergence of Clinical and Nonclinical Considerations [0.03%]
以患者为中心的药品质量标准：临床与非临床因素的一致性
Stan Altan,Hans Coppenolle,Trine Kvist et al.
Stan Altan et al.
A special panel session at the 2024 NCS Conference in Wiesbaden, Germany, brought together experts to explore the evolving landscape of patient-centric drug product development and specifications. Traditional specifications often rely on ma...
Integrated Population Pharmacokinetic-pharmacodynamic Modeling of HIV Virus-host Infection Dynamics in Patients Undergoing Antiretroviral Monotherapy [0.03%]
抗逆转录病毒单药治疗患者的HIV病毒-宿主感染动力学的综合群体药代动力学和药效学建模
Alberto Vegas Rodriguez,Nieves Velez de Mendizábal,Yanan Zheng et al.
Alberto Vegas Rodriguez et al.
Chronic human immunodeficiency virus (HIV) infection continues to pose a major global health challenge, with an estimated 39.9 M cases and 1.3 M new infections per year. Up to 75%, of people with HIV (PWH) are currently being treated with a...
Affinity Capture Elution Coupled with Cell-based Cyclic Adenosine Monophosphate Assay as a Platform Method for Detection of Neutralizing Antibodies to Incretin Molecules [0.03%]
用于检测中和性抗体的亲合力捕获结合细胞基质环腺苷酸测定法作为平台方法
Nichole A Reynolds,Yan Q Chen,Richard E Higgs et al.
Nichole A Reynolds et al.
Formation of anti-drug antibodies (ADA) and, in particular, neutralizing antibodies (NAb), is a major risk to the development of biotherapeutics. Cell-based assays, which can reflect the mechanistic interactions among the drug, target, and ...
Effective Visualizations Using "vachette" to Assess and Communicate Pharmacometric Model Results [0.03%]
利用"vachette"有效可视化药代动力学模型结果以评估和交流
Jos Lommerse,Anna Largajolli,James Craig et al.
Jos Lommerse et al.
Using pharmacometrics to inform drug discovery and development decisions requires effective communication of models and data to all stakeholders. The new "vachette" visualization method presented here enables modelers and non-modelers to se...
Lu Huang,Yinbo Chen,Satyendra Suryawanshi et al.
Lu Huang et al.
QSP models are increasingly being applied to drug development. Calibrating virtual populations (VPops) to clinical data helps explore patient variability, study populations of interest, and predict clinical outcomes for new therapies. In pr...
Reanalysis of Plasma Samples Collected from a CRO Reveals Possible Patterns of Bioanalytical Misconduct [0.03%]
第三方实验室收集的血浆样本的再分析发现了生物分析不当行为的可能模式
Jinhui Zhang,Charles Bonapace,Arindam Dasgupta et al.
Jinhui Zhang et al.
Data integrity is necessary to help ensure the accuracy, consistency, validity and completeness of data. Data can be untraceably manipulated when it lacks adequate integrity. The FDA identified data integrity concerns with the pharmacokinet...
Physiologically Based Pharmacokinetic Modeling and Simulation in Regulatory Review: US FDA CBER Experience and Perspectives [0.03%]
基于生理的药代动力学模型与模拟在监管审评中的应用：美国FDA(CBER)的经验和观点
Million A Tegenge,Osman N Yogurtcu,Artur A Belov et al.
Million A Tegenge et al.
Physiologically based pharmacokinetic (PBPK) modeling has emerged as a valuable tool in model-informed drug development (MIDD). This approach enables the integration of diverse experimental data to predict pharmacokinetics (PK) and dosing r...
Correction: One-step Immobilization of Human α-1-acid Glycoprotein on Magnetic Beads: A Rapid Method for Small Molecule hAGP Binding Study [0.03%]
订正：人α-1酸性糖蛋白一次性固定在磁珠上：一种快速的小分子hAGP结合研究方法
Ting Wang,Hamid Samareh Afsari,Steven Anderlot et al.
Ting Wang et al.
Published Erratum
The AAPS journal. 2025 Oct 8;27(6):156. DOI:10.1208/s12248-025-01160-4 2025
A Quantitative Approach to Guiding Target Antigen Selection and Antibody Optimization in Recycling Antibody Discovery [0.03%]
循环抗体发现中靶标抗原选择和抗体优化的定量方法研究
Hamed Ghaffari,Bernard P Murray,Isabel Figueroa et al.
Hamed Ghaffari et al.
Recycling antibodies can enhance therapeutic efficacy by enabling efficient antigen removal through pH-dependent binding mechanisms enabling antibody recycling, but the optimal targets for this strategy remain unclear. This work employs a m...
Applications of PBPK Models to Predict Tissue Residues and Extralabel Withdrawal Times of Drugs in Food Animals: Perspectives from the Food Animal Residue Avoidance Databank (FARAD) Program [0.03%]
预测药物在食品动物中的组织残留和超出标签的停药期的PBPK模型应用：来自食品动物残留规避数据库(FARAD)项目的观点
Zhoumeng Lin,Xue Wu,Kun Mi et al.
Zhoumeng Lin et al.
Physiologically based pharmacokinetic (PBPK) models are commonly used in human drug discovery and development and human health risk assessment of environmental chemicals. One emerging application of PBPK models is to predict tissue residues...