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
Clinical Pharmacology & Model-Informed Drug Development Insights for Targeted Radiation Therapies On-Demand Webinar 靶向放射治疗的临床药理学和模型引导的药物开发启示 靶向放射性核素治疗(TRT)通过将细胞毒性辐射选择性作用于肿瘤实现精准治疗。In recent years, oncology drug…Danielle Pillsbury2024 年 5 月 22 日
What you should know about FDA Project Optimus for your oncology drug approval On-Demand Webinar 关于 FDA Project Optimus,您应该了解哪些有关肿瘤药物审批的信息 一直以来,肿瘤药物的剂量策略都以最大耐受剂量为重点。This…Danielle Pillsbury2023 年 3 月 10 日
Why FDA’s New Guidance on Circulating Tumor DNA is Critical for Oncology Early Clinical Drug Development Blog 为什么 FDA 关于循环肿瘤 DNA 的新指南对肿瘤早期临床药物开发至关重要 2022 is shaping up to be the “year of the guidance” as the FDA has…Becca Bucci2022 年 7 月 1 日
eChalk Talk: How Oncology Drug Developers Can Prepare for FDA’s Project Optimus On-Demand Webinar eChalk Talk: 肿瘤药物开发商如何为 FDA Project Optimus 做好准备 Historically, the dosing strategy for oncology drugs has focused on use of the maximum tolerated…Jim Gallagher2022 年 3 月 22 日
什么是 FDA Project Optimus?它会如何影响肿瘤药物开发? 博客 什么是 FDA Project Optimus?它会如何影响肿瘤药物开发? Project Optimus is an initiative proposed by the U.S. Food and Drug Administration’s Oncology Center…Jim Gallagher2022 年 2 月 2 日
What Oncology Drug Developers Should Expect from the FDA’s Project Optimus On-Demand Webinar 肿瘤药物开发人员应该从 FDA Project Optimus 中期待获得什么? 一直以来,肿瘤药物的剂量策略都以最大耐受剂量为重点。This…Jim Gallagher2022 年 1 月 13 日
How New FDA Guidance Project Optimus May Affect Future of Oncology Clinical Trials, Drug Pipeline Article 全新 FDA 指南 Project Optimus 可能如何影响肿瘤学临床试验和药物研究计划的未来 Julie Bullock, VP, global head of clinical pharmacology and translational medicine at Certara, discusses the…Jim Gallagher2021 年 8 月 16 日