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
A Pharmacokinetic Analysis of Drug Concentration Using a Novel Deep Learning Model Poster 利用新型深度学习模型进行药物浓度的药代动力学分析 Certara2024 年 11 月 22 日
Model-Informed Drug Development Framework for the Development and Dose Optimization of Targeted Radiation Therapies Poster 用于开发和优化靶向辐射疗法剂量的模型引导的药物开发框架 Certara2024 年 11 月 22 日
Oncology MIDD Simulator, A User-Friendly Application for Overall Survival Forecasting in Early Oncology Trials Poster Oncology MIDD Simulator — 用于早期肿瘤学试验总生存期预测的用户友好型应用程序 Certara2024 年 11 月 22 日
Population pharmacokinetic modeling of niraparib to assess different absorption models Poster 尼拉帕利(Niraparib)群体药代动力学建模以评估不同吸收模型 Certara2024 年 11 月 22 日
PBPK Modeling to Support Bioequivalence & Generic Product Approvals Blog 支持生物等效性和仿制药审批的 PBPK 建模 Physiologically-based pharmacokinetic modeling can be used to support bioequivalence (BE) assessment of complex and locally…Certara2024 年 11 月 12 日
A Sequential Population Pharmacokinetic Model of Zilovertamab Vedotin in Patients with Hematologic Malignancies Extrapolated to the Pediatric Population Publication Zilovertamab Vedotin 在血液恶性肿瘤患者中的序贯群体药代动力学模型推断至儿童群体 Certara2024 年 11 月 7 日