Critical Roles for Modeling and Simulation and Real-World Evidence to Inform Challenges in Clinical Trial Diversity Planning Publication 建模与模拟及真实世界证据在临床试验多样性规划中的关键作用:挑战应对策略 Due to the highly controlled settings of clinical trials, enrolled subjects may not be fully…Danielle Pillsbury2025 年 6 月 19 日
From Data to Decisions: Real-World Impact of Model-Based Meta-Analysis (MBMA) with GSK and Certara Webinar 从数据到决策:基于模型的荟萃分析(MBMA)与 GSK 和 Certara 真实世界影响 Certara2025 年 6 月 18 日
Assessment of the Effects of Fruquintinib on Cardiac Safety in Patients with Metastatic Colorectal Cancer Publication Assessment of the Effects of Fruquintinib on Cardiac Safety in Patients with Metastatic Colorectal Cancer The study, published in the Journal of Clinical Pharmacology, evaluates the cardiac safety of fruquintinib,…Certara2025 年 6 月 8 日
Safety of combined long-acting injectable cabotegravir and long-acting injectable rilpivirine in virologically suppressed adolescents with HIV (IMPAACT 2017/MOCHA): a phase 1/2, multicentre, open-label, non-comparative, dose-finding study Publication HIV 病毒学抑制青少年中长效注射用 cabotegravir 与长效注射用 rilpivirine 联合用药的安全性研究(IMPAACT 2017/MOCHA):一项 1/2 期、多中心、开放标签、非比较性的剂量探索研究 The IMPAACT 2017/MOCHA study, a phase 1/2 multicenter trial across five countries, assessed the safety,…Certara2025 年 3 月 20 日
Gene Therapy: A Transformative Shift in Rare Disease Treatment Video Gene Therapy: A Transformative Shift in Rare Disease Treatment After decades of promise, gene therapy is finally starting to deliver on its potential—especially for…Certara2025 年 2 月 26 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
2025 cell and gene challenges: Scalability, supply chain and manufacturing Press Coverage 2025 cell and gene challenges: Scalability, supply chain and manufacturing Explore insights on 2025 challenges in cell and gene therapy, including commercial viability, with expert…Certara2025 年 2 月 3 日
Why FDA’s omaveloxolone approval for Friedreich’s ataxia matters Blog 为何 FDA 批准 omaveloxolone 用于治疗弗里德赖希共济失调症意义重大 2025 年 1 月 10 日 Friedreich’s Ataxia (FA) is a rare, genetic, and progressive neurodegenerative disorder. A…Certara2025 年 1 月 10 日
Preclinical data exposures underpredict clinical physiologically active doses for bispecific T-cell engagers in solid tumors indications; are there better metrics? -insights from a small mechanistic MBMA Poster 临床前数据暴露无法预测双特异性 T 细胞吸引剂在实体瘤适应症中的临床生理活性剂量;是否有更好的衡量标准?— 来自小型机制性 MBMA 的启示 Certara2024 年 12 月 11 日
Simultaneous Population PKPD Analysis of Belantamab Mafodotin, Soluble BCMA, and Serum M-Protein in Subjects With Relapsed/Refractory Multiple Myeloma Poster 复发/难治性多发性骨髓瘤患者 Belantamab Mafodotin、可溶性B细胞成熟抗原(BCMA)和血清 M-蛋白的群体药代动力学-药效学(PKPD)同步分析 Certara2024 年 11 月 22 日