Rosuvastatin PBPK Modeling: Incorporating Liver Concentrations and Effects of Ethnicity, Genetic Polymorphisms, Lactone Formation, DDI and Pregnancy [0.03%]
rosuvastatin PBPK 模型：纳入肝脏浓度及种族、遗传多态性、内酯形成、药物相互作用和妊娠的影响
Ankit Balhara,Robert H Weber,Jashvant D Unadkat
Ankit Balhara
Rosuvastatin (RSV), a potent HMG-CoA reductase inhibitor, is widely used for the management of hyperlipidemia and prevention of cardiovascular disease. Its absorption and disposition are primarily transporter-mediated, involving intestinal ...
Model-Informed Drug Development for Ligelizumab in Patients With Chronic Spontaneous Urticaria [0.03%]
用于慢性自发性荨麻疹患者的ligelizumab药物开发的模型指导方法学研究
Andrzej Bienczak,Aurelie Gautier,Eva Hua et al.
Andrzej Bienczak et al.
Model-informed drug development (MIDD) has been increasingly applied to guide decision-making, ameliorate efficiency, and enhance the likelihood of successful trials. The development of ligelizumab, a humanized anti-IgE monoclonal antibody,...
A Combined Modeling Approach to Predict the Effect of Gastric Emptying Delay on the Pharmacokinetics of Small Molecules [0.03%]
胃排空延迟对小分子药代动力学影响的组合建模预测方法研究
Maria M Posada,Karen B Schneck,Bridget L Morse et al.
Maria M Posada et al.
Dulaglutide, a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist, is approved for improving glycemic control and reducing cardiovascular risks in patients with type 2 diabetes mellitus (T2DM). This research investigates the effec...
Population Pharmacokinetic Model of Pegbing in Healthy Subjects and Chronic Hepatitis B Patients [0.03%]
健康受试者和慢性乙型肝炎患者接受佩加他韦(Pegbing)药代动力学人群模型研究
Weizhe Jian,Yalin Yin,Rong Chen et al.
Weizhe Jian et al.
Pegbing (peginterferon alpha-2b) is a polyethylene glycol-modified interferon α-2b injection that has demonstrated favorable efficacy and safety profiles in the treatment of chronic hepatitis B (CHB). This study aimed to develop a populati...
A Bayesian Approach to Compare Accumulating Survival Data From Clinical Practice With RCT Data: A Case Study in Non-Small Cell Lung Cancer Patients [0.03%]
贝叶斯方法比较临床实践中积累的生存数据与随机对照试验数据——以非小细胞肺癌患者为例
Marjon V Verschueren,Daniel V Verschueren,Ewoudt M W van de Garde et al.
Marjon V Verschueren et al.
Survival outcomes observed in randomized controlled trials (RCTs) may not always be generalizable to clinical practice. Evaluating whether treatment outcomes in clinical practice are similar to those in RCTs shortly after a new medicine is ...
Exposure-Response Analysis of Repotrectinib to Support the Dose Recommendation for Patients With ROS1-Positive NSCLC or NTRK-Positive Solid Tumors [0.03%]
Repotrectinib的暴露反应分析支持ROS1阳性NSCLC或NTRK阳性实体瘤患者的剂量推荐
Shengnan Du,Zheyi Hu,Jun Shen et al.
Shengnan Du et al.
To support the benefit-risk assessment and dose justification of repotrectinib for patients with c-ros oncogene 1 (ROS1) positive non-small cell lung cancer (NSCLC) or neurotrophin receptor tyrosine kinase (NTRK)-positive solid tumors, expo...
Toward a Quantitative Understanding of Aficamten Clinical Pharmacology: Population Pharmacokinetic Modeling [0.03%]
朝向定量理解Aficamten临床药理学：人群药代动力学建模
Donghong Xu,Hanbin Li,Stephen B Heitner et al.
Donghong Xu et al.
Aficamten is a next-in-class, cardiac myosin inhibitor in development as a potential chronic oral treatment for patients with hypertrophic cardiomyopathy (HCM). A population pharmacokinetic (PK) model was developed using data from nine clin...
Alex Foster-Powell,Amin Rostami-Hodjegan,Guy Meno-Tetang et al.
Alex Foster-Powell et al.
Age-related neurodegenerative diseases such as amyotrophic lateral sclerosis (ALS), Alzheimer's disease (AD) and Parkinson's disease (PD) are an increasing public health concern. Whereas the pathology of these diseases is complex, chronic c...
A Perspective on the Use of Poisson Versus Logistic Regression in Exposure-Response Analysis: Insights and Considerations [0.03%]
关于暴露反应分析中使用泊松回归和逻辑回归的视角：见解与考量
Yiming Cheng,Ping Chen,Yan Li
Yiming Cheng
This perspective evaluates the use of Poisson versus logistic regression in modeling binary exposure-response (ER) data. Through simulation studies across varying sample sizes, event rates, and ER slopes, we highlight the strengths and limi...
A Systematic Comparative Analysis of Tumor Size Models Based on Erlotinib Clinical Data in Advanced NSCLC [0.03%]
基于厄洛替尼临床数据的晚期非小细胞肺癌肿瘤体积模型的系统比较分析
Anna Mishina,Kirill Zhudenkov,Gabriel Helmlinger et al.
Anna Mishina et al.
Early assessment of efficacy and dose optimization remain critical challenges in the development of anticancer therapies. Empirical models of solid tumor size dynamics-a key prognostic biomarker-have played a central role in addressing thes...