Yasuhiko Imai,Emi Akatsu,Suzanne K Minton
Yasuhiko Imai
'Drug loss' in Japan refers to drugs that have been approved and marketed overseas but haven't been developed, submitted, or approved in Japan. A comprehensive Model-Informed Drug Development (MIDD) strategy, enhanced with artificial intell...
Optimizing Ibrutinib Posology in Chronic Lymphocytic Leukemia Using a Semi-Mechanistic Pharmacometric Framework [0.03%]
基于半机制药理学模型的伊布替尼剂量调整以优化慢性淋巴细胞白血病患者的治疗效果
Eman I K Ibrahim,Lena E Friberg
Eman I K Ibrahim
Ibrutinib, a Bruton's tyrosine kinase (Btk) inhibitor, is a key therapy for chronic lymphocytic leukemia (CLL). In clinical practice, adverse events, such as hypertension, frequently necessitate dose reductions or treatment discontinuation....
A Step-by-Step Workflow for Performing In Silico Clinical Trials With Nonlinear Mixed Effects Models [0.03%]
基于非线性混合效应模型的数字临床试验工作流程指导
Javiera Cortés-Ríos,Mindy Magee,Anna Sher et al.
Javiera Cortés-Ríos et al.
In silico clinical trials (ISCT) are computational frameworks that employ mathematical models to generate virtual patients and simulate their responses to new treatments, treatment regimens, or medical devices via simulations mirroring real...
A Unified Whole Lung PBK Model for Inhalational Uptake of Gases and Aerosols in Men [0.03%]
一种用于男性吸入暴露的气体和气溶胶统一肺部命运模型
Norman Nowak,Sylvia E Escher,Katharina Schwarz
Norman Nowak
Assessing the risk or benefit of an inhaled substance is challenging due to the variety of forms it can take (gas, vapor, particle, or droplet) and the complex biological processes involved in its uptake and retention. Physiologically based...
Population Pharmacokinetic and Pharmacodynamic Modeling for the Prediction of the Extended Amlitelimab Phase 3 Dosing Regimen in Atopic Dermatitis [0.03%]
用于预测氨甲特利单抗扩展第3阶段给药方案的过敏性皮炎人群药物代谢动力学和药物效应动力学建模
Gilles Tiraboschi,Kim Papp,Thomas Bieber et al.
Gilles Tiraboschi et al.
Amlitelimab is a fully human, nondepleting, anti-OX40 ligand monoclonal antibody being investigated for the treatment of moderate-to-severe atopic dermatitis (AD) in adults and adolescents. Population pharmacokinetic (PopPK) and pharmacokin...
Population Pharmacokinetic Analysis of Datopotamab Deruxtecan (Dato-DXd), a TROP2-Directed Antibody-Drug Conjugate, in Patients With Advanced Solid Tumors [0.03%]
一种针对TROP2的抗体药物偶联物datopotamab deruxtecan（Dato-DXd）在晚期实体瘤患者中的群体药代动力学分析
Ying Hong,Sophie Peigné,Υuzhuo Pan et al.
Ying Hong et al.
Datopotamab deruxtecan (Dato-DXd) is a trophoblast cell surface antigen 2 (TROP2)-directed antibody-drug conjugate (ADC) developed for the treatment of advanced or metastatic solid tumors. Dato-DXd demonstrated promising antitumor activity ...
A Model-Based Meta-Analysis of Pembrolizumab Effects on Patient-Reported Quality of Life: Advancing Patient-Centered Oncology Drug Development [0.03%]
基于模型的 meta 分析：帕博利珠单抗对患者报告的生活质量的影响：以患者为中心的肿瘤药物开发的新进展
Yiqin Zou,Yimeng Sun,Sudhamshu Ravva et al.
Yiqin Zou et al.
Pembrolizumab is an immune checkpoint inhibitor that has been approved for more than 20 different indications and has shown great survival benefits in various types of cancer. However, the reported benefits of pembrolizumab in patients' qua...
Using Virtual Patients to Evaluate Dosing Strategies for Bispecifics With a Bell-Shaped Efficacy Curve [0.03%]
使用虚拟患者评估具有钟形效应曲线的双特异性药物给药策略
Jana L Gevertz,Irina Kareva
Jana L Gevertz
Bispecific antibodies can be broadly divided into two categories: those that are pharmacologically active as either dimers bound to a single target or as trimers bound to both targets, and those that are only active as trimers. Dose selecti...
PD-1-Cis IL-2R Agonism Determines the Predicted Pharmacological Dose Range for the Immunocytokine Eciskafusp Alfa (PD1-IL2v) [0.03%]
PD-1-细胞结合型IL-2受体激动剂免疫细胞因子Ecilimotupalfa(PD1-IL2v)的药理剂量范围预测
Lucy G Hutchinson,Thomas D Lewin,Laura Lauener et al.
Lucy G Hutchinson et al.
Binding in cis-configuration to the PD-1 receptor (PD-1) and IL-2 βγ $$ /beta /gamma $$ receptor (IL-2R βγ $$ /beta /gamma $$ ) has been shown to lead to differentiation of CD8 T cells to better effectors, which is a...
Evaluation and Mitigation of Time-Dependent Confounding Effects in Conventional Exposure-Response Analyses for Oncology Drugs [0.03%]
评估和缓解传统抗癌药物暴露反应分析中的时间依赖性混杂效应及其减轻措施
Xuefen Yin,Ye Xiong,Youwei Bi et al.
Xuefen Yin et al.
Conventional exposure-response (E-R) analyses, such as logistic regression and time-to-event analysis using summary exposure metrics, are often conducted in oncology using data from the pivotal trial(s) with a single dose level to support d...