Learn-confirm in model-informed drug development: Assessing an immunogenicity quantitative systems pharmacology platform Publication 在模型引导的药物开发中实施“学习-确认”策略:评估免疫原性定量系统药理学平台 Immunogenicity against therapeutic proteins frequently causes attrition owing to its potential impact on pharmacokinetics, pharmacodynamics,…Certara2025 年 2 月 10 日
Population Pharmacokinetic and Pharmacodynamic Analysis of Navtemadlin in Patients with Relapsed and Refractory (R/R) Myelofibrosis (MF) and Other Myeloid or Solid Tumor Malignancies Publication 针对复发难治性(R/R)骨髓纤维化(MF)及其他髓系或实体瘤恶性肿瘤患者的 Navtemadlin 群体药代动力学与药效学分析 This study conducted a population pharmacokinetic (PK) and pharmacodynamic (PD) analysis of navtemadlin, an MDM2…Certara2025 年 2 月 6 日
Understanding Variability in CAR-T Cell Therapy Kinetics Publication 了解 CAR-T 细胞疗法动力学的变异性 Axicabtagene ciloleucel (axi-cel), a CAR-T cell therapy for relapsed and refractory non-Hodgkin’s lymphoma (NHL), demonstrates…Certara2025 年 1 月 23 日
Impact of using time-averaged exposure metrics on binary endpoints in exposure-response analyses Publication 在暴露-反应分析中使用时间平均暴露指标对二元终点的影响 This Frontiers in Pharmacology article investigates how using different time-averaged exposure metrics, specifically the time-averaged…Certara2025 年 1 月 21 日
Management of Vulnerable Patients Hospitalized for COVID-19 With Remdesivir: A Retrospective Comparative Effectiveness Study of Mortality in US Hospitals Publication 针对使用瑞德西韦(Vulnerable)治疗的 COVID-19 住院脆弱患者的管理:一项美国医院死亡率回顾性比较效果研究 Background Coronavirus disease 2019 (COVID-19) remains a major public health concern, with continued resurgences of…Certara2025 年 1 月 16 日
Model-informed drug discovery and development approaches to inform clinical trial design and regulatory decisions: A primer for the MENA region Publication 利用模型引导的药物开发(MIDD)方法以优化临床试验设计与监管决策面向中东和北非地区(MENA)的入门指南 The integration of MID3 offers a transformative opportunity for the MENA region to advance pharmaceutical…Certara2025 年 1 月 14 日
INTERCEPT-AD, a phase 1 study of intravenous sabirnetug in participants with mild cognitive impairment or mild dementia due to Alzheimer’s disease Publication INTERCEPT-AD:一项针对阿尔茨海默病所致轻度认知障碍或轻度痴呆患者的静脉注射 Sabirnetug 的 I 期研究 The Phase 1 INTERCEPT-AD study evaluated sabirnetug (ACU193), a monoclonal antibody targeting amyloid-beta oligomers (AβOs),…Certara2025 年 1 月 8 日
Static Versus Dynamic Model Predictions of Competitive Inhibitory Metabolic Drug–Drug Interactions via Cytochromes P450: One Step Forward and Two Steps Backwards Publication 通过细胞色素 P450 的竞争性抑制代谢药物-药物相互作用的静态与动态模型预测:前进一步,后退两步 Predicting metabolic drug–drug interactions (DDIs) via cytochrome P450 enzymes (CYP) is essential in drug development,…Certara2024 年 12 月 12 日
Advancing pharmacometrics in Africa – Transition from capacity development toward job creation Publication 推动非洲定量药理学的发展 — 从能力建设向创造就业过渡 This CPT article showcases, the Applied Pharmacometrics Training (APT) program, launched in 2021 by Pharmacometrics…Certara2024 年 12 月 9 日
Quantitative Systems Pharmacology-Based Digital Twins Approach Supplements Clinical Trial Data for Enzyme Replacement Therapies in Pompe Disease Publication 基于定量系统药理学的数字双胞胎方法补充了庞贝氏症酶替代疗法的临床试验数据 Pompe disease is a rare, progressive neuromuscular disease caused by deficient lysosomal glycogen degradation, and…Certara2024 年 12 月 4 日