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…Jim Gallagher2024 年 11 月 12 日
A Sequential Population Pharmacokinetic Model of Zilovertamab Vedotin in Patients with Hematologic Malignancies Extrapolated to the Pediatric Population Publication 齐洛韦坦单抗维多汀(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 Danielle Pillsbury2024 年 11 月 7 日
Mathematical Models can Assist in Broadening use of Immuno-oncology Drugs to Treat Autoimmunity Blog 数学模型有助于扩大免疫肿瘤药物治疗自身免疫疾病的应用范围 Connecting Cancer and Autoimmunity "The dosing regimens in oncology may not directly inform the optimal…Renee Fisher2024 年 10 月 31 日
RAPS Sponsored Webcast: Optimizing Pediatric Oncology Drug Development: A Comprehensive Overview On-Demand Webinar RAPS 主办的网络广播:Optimizing Pediatric Oncology Drug Development: A Comprehensive Overview Developing safe and effective oncology medications for children presents unique challenges due to ethical considerations…Danielle Pillsbury2024 年 10 月 17 日
Quantitative Systems Pharmacology (QSP) Enabled First-in-Human Study in Oncology On-Demand Webinar 基于定量系统药理学(QSP)的肿瘤学首次人体试验研究 Renee Fisher2024 年 9 月 16 日
Using Quantitative Systems Pharmacology (QSP) Modeling for Oncology Dose Optimization On-Demand Webinar Using Quantitative Systems Pharmacology (QSP) Modeling for Oncology Dose Optimization The FDA’s Project Optimus initiative aims to reform dose optimization and selection for oncology therapies…Danielle Pillsbury2024 年 8 月 19 日
Optimizing Clinical Development: Saving Time and Costs Case Study 优化临床开发:节约时间和成本 战略机械建模解决方案可帮助免疫肿瘤生物技术加速其新型疗法的临床开发。Danielle Pillsbury2024 年 8 月 16 日
Medicines that matter: Biohaven’s Nurtec™ drug development journey Case Study 重塑医药未来:Biohaven 公司 Nurtec™ 药物的研发之旅 In February 2020, Biohaven Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) approved…webdev2024 年 8 月 15 日
Model-Informed Confidence in Oncology Dose Selection Case Study 肿瘤学剂量选择中模型引导的决策信心 Discover an oncology-focused company that gained confidence in their dose selection for an AML trial…Danielle Pillsbury2024 年 8 月 9 日
Certara’s MIDD Oncology Capabilities Video Certara 在 MIDD 领域的肿瘤学解决能力 Improve Oncology Study Decisions with Certara's MIDD Team Transcript: The pace of oncology drug…Simona Colucci2024 年 8 月 7 日