Accelerating Oncology Drug FDA Submission with Project Management Services Case Study 通过项目管理服务加速肿瘤药物 FDA 申报流程 Discover how Certara’s dedicated project management and pharmacometric support helped an emerging biotech company fast-track…Certara2025 年 7 月 2 日
Mechanistic Modeling Guides Bispecific Antibody Design and Target Selection for Maximizing Therapeutic Window Poster 机制建模指导双特异性抗体设计和靶标选择,最大限度地扩大治疗窗口 Therapeutic antibodies have shown promise in treating diseases such as cancer, but selectivity remains a…Certara2025 年 3 月 28 日
QSP Modeling Optimizes FIH Dose Selection for Multiple Myeloma Therapy Case Study QSP 建模优化多发性骨髓瘤疗法的首次人体试验剂量选择 Multiple myeloma, the second most common blood cancer, affects an estimated 160,000 individuals annually worldwide…Certara2025 年 3 月 25 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
Postmarketing Assessment of Antibody–Drug Conjugates: Proof-of-Concept Using Model-Based Meta-Analysis and a Clinical Utility Index Approach Publication Postmarketing Assessment of Antibody–Drug Conjugates: Proof-of-Concept Using Model-Based Meta-Analysis and a Clinical Utility Index Approach This study explores a model-based meta-analysis (MBMA) and a clinical utility index (CUI) approach to…Certara2025 年 3 月 4 日
Rare Oncology Product Launch Playbook: Universal Strategies for Success in the U.S. and Europe White Paper 罕见肿瘤学产品发布手册:在美国和欧洲取得成功的通用策略 Lorem ipsum dolor sit amet consectetur. At venenatis urna sapien ut lorem enim. Morbi lectus…Certara2025 年 2 月 28 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
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