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…CertaraAugust 19, 2024
Clinical Pharmacology & Model-Informed Drug Development Insights for Targeted Radiation Therapies On-Demand Webinar Clinical Pharmacology & Model-Informed Drug Development Insights for Targeted Radiation Therapies Targeted radiation therapies (TRT) deliver cytotoxic radiation selectively to tumors. In recent years, oncology drug…CertaraMay 22, 2024
What you should know about FDA Project Optimus for your oncology drug approval On-Demand Webinar What you should know about FDA Project Optimus for your oncology drug approval Historically, the dosing strategy for oncology drugs has focused on the maximum tolerated dose. This…CertaraMarch 10, 2023
Why FDA’s New Guidance on Circulating Tumor DNA is Critical for Oncology Early Clinical Drug Development Blog Why FDA’s New Guidance on Circulating Tumor DNA is Critical for Oncology Early Clinical Drug Development 2022 is shaping up to be the “year of the guidance” as the FDA has…CertaraJuly 1, 2022
eChalk Talk: How Oncology Drug Developers Can Prepare for FDA’s Project Optimus On-Demand Webinar eChalk Talk: How Oncology Drug Developers Can Prepare for FDA’s Project Optimus Historically, the dosing strategy for oncology drugs has focused on use of the maximum tolerated…CertaraMarch 22, 2022
What is the FDA’s Project Optimus & How Will it Affect Oncology Drug Development? Blog What is the FDA’s Project Optimus & How Will it Affect Oncology Drug Development? Project Optimus is an initiative proposed by the U.S. Food and Drug Administration’s Oncology Center…CertaraFebruary 2, 2022
What Oncology Drug Developers Should Expect from the FDA’s Project Optimus On-Demand Webinar What Oncology Drug Developers Should Expect from the FDA’s Project Optimus Historically, the dosing strategy for oncology drugs has focused on the maximum tolerated dose. This…CertaraJanuary 13, 2022
How New FDA Guidance Project Optimus May Affect Future of Oncology Clinical Trials, Drug Pipeline Press Coverage How New FDA Guidance Project Optimus May Affect Future of Oncology Clinical Trials, Drug Pipeline Julie Bullock, VP, global head of clinical pharmacology and translational medicine at Certara, discusses the…CertaraAugust 16, 2021