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 dose. This has resulted in drugs’ pharmacokinetic (PK) profiles, pharmacokinetic/pharmacodynamic (PK/PD) relationships, and clinical target inhibition largely being ignored in the dose decision making process. Thus, cancer patients often struggle to tolerate their medication long-term, requiring dose modifications including dose … Continued
https://www.certara.com/on-demand-webinar/echalk-talk-how-oncology-drug-developers-can-prepare-for-fdas-project-optimus/