The Basel Modeling and Simulation Seminar: 20 Editions of Fostering Local Exchange in Pharmacometrics [0.03%]
巴斯尔建模与模拟研讨会： pharmacometrics领域的地方交流培育二十载纪念
Tamara van Donge,João A Abrantes,Kai Grosch et al.
Tamara van Donge et al.
This year marks the 20th edition of the Basel Modeling and Simulation (M&S) Seminar, an initiative rooted in a commitment to promoting the exchange of the latest advancements in pharmacometrics and related disciplines in the region of Basel...
Machine Learning-Based Model Selection and Averaging Outperform Single-Model Approaches for a Priori Vancomycin Precision Dosing [0.03%]
基于机器学习的模型选择和平均优于单一模型的优先方案用于万古霉素精准给药
Wisse van Os,Amaury O&#x;Jeanson,Carla Troisi et al.
Wisse van Os et al.
Selecting an appropriate population pharmacokinetic (PK) model for individual patients in model-informed precision dosing (MIPD) can be challenging, particularly in the absence of therapeutic drug monitoring (TDM) samples. We developed a ma...
Optimizing First-Line Therapeutics in Non-Small Cell Lung Cancer: Insights From Joint Modeling and Large-Scale Data Analysis [0.03%]
基于联合模型和大规模数据分析的非小细胞肺癌一线治疗优化研究
Benjamin K Schneider,Sebastien Benzekry,Jonathan P Mochel
Benjamin K Schneider
Non-small cell lung cancer (NSCLC) is often intrinsically resistant to several first- and second-line therapeutics and can rapidly acquire further resistance after a patient begins treatment. Treatment outcomes are, therefore, significantly...
Mitigating Trastuzumab-Doxorubicin Cardiotoxicity With Multiscale Quantitative Systems Toxicology and PBPK-Toxicodynamic Predictive Modeling Framework [0.03%]
采用多尺度定量系统毒理学和PBPK-毒性动力学预测模型框架缓解曲妥珠单抗-多柔比星的心脏毒性
Sijia Yu,Hardik Mody,Tanaya R Vaidya et al.
Sijia Yu et al.
Doxorubicin (DOX) and trastuzumab (TmAb) are widely used to treat HER2-positive breast cancer (BC), as monotherapies and in combination (DOX + TmAb). While highly effective, their combined use significantly increases the risk of irreversibl...
Predicting Residual 21-Hydroxylase Enzymatic Activity in Pediatric and Adult Congenital Adrenal Hyperplasia Patients: Towards Individualized Therapy [0.03%]
预测儿童和成人先天性肾上腺皮质增生患者残余21-羟化酶活性：迈向个体化治疗
Davide Bindellini,Robin Michelet,Yersultan Mirasbekov et al.
Davide Bindellini et al.
Congenital adrenal hyperplasia (CAH) is a genetic disorder characterized by impaired cortisol production and consequent elevated adrenocorticotropic hormone (ACTH): CAH patients often require lifelong hydrocortisone therapy. Disease severit...
Impact of Mechanistic Modeling and Simulation Methodologies on Product-Specific Guidance Development for Non-Orally Administered Drug Products [0.03%]
机制建模和仿真方法学对非口服给药产品特异性指导开发的影响
Steven G Chopski,Ross L Walenga,Ming-Liang Tan et al.
Steven G Chopski et al.
The U.S. Food and Drug Administration (FDA) publishes product-specific guidances (PSGs), with bioequivalence (BE) recommendations for prospective generics. Developing BE recommendations for non-orally administered drug products including lo...
State-of-the-Art on Model-Informed Drug Development Approaches for Pediatric Rare Diseases [0.03%]
儿科罕见病模型引导药物研发的最新进展
Rajesh Krishna,Amitava Mitra,Matthew L Zierhut et al.
Rajesh Krishna et al.
Pediatric rare diseases present unique challenges for drug development due to small patient populations, ethical constraints on clinical trial design, and limited prospectively defined natural history data. Model-Informed Drug Development (...
Isavuconazole and Calcium Channel Blocker for Invasive Fungal Disease Accompanied With Hypertension: Evidence From the FAERS and PBPK/PD Model [0.03%]
异血管康唑与钙通道阻滞剂治疗侵袭性真菌感染合并高血压：来自FAERS和PBPK / PD模型的证据
Jianxing Zhou,Bo Xiao,Zipeng Wei et al.
Jianxing Zhou et al.
Patients with invasive fungal disease (IFD) frequently present with hypertension, necessitating polypharmacy and increasing the risk of drug-drug interactions (DDIs). This study evaluated the safety of combining isavuconazole (ISA), a triaz...
Mechanism-Based Modeling Approaches to Quantify the Effect of Immunogenicity on the Pharmacokinetics of Therapeutic Proteins in Drug Development [0.03%]
基于机制的建模方法量化免疫原性对药物开发中治疗蛋白药代动力学的影响
Paridhi Gupta,Josiah T Ryman,Vibha Jawa et al.
Paridhi Gupta et al.
Therapeutic protein administration in both preclinical and clinical studies can result in the formation of anti-drug antibodies against the therapeutic protein. Anti-drug antibody formation may alter the pharmacokinetics of the therapeutic ...
Integrated Modeling of Digital-Motor and Clinician-Reported Outcomes Using Item Response Theory: Towards Powerful Trials for Rare Neurological Diseases [0.03%]
基于项目反应理论的数字评分量表和临床医生评估结果综合建模：罕见神经系统疾病的试验设计优化方法学研究
Alzahra Hamdan,Andreas Traschütz,Lukas Beichert et al.
Alzahra Hamdan et al.
Robust and highly sensitive outcomes are crucial for small trials in rare diseases. Combining different outcome types might improve sensitivity to identify disease severity and progression, yet innovative methodologies are scarce. Here we d...