[HTML][HTML] Integrated modeling of biomarkers, survival and safety in clinical oncology drug development
Abstract Model-based approaches, including population pharmacokinetic-
pharmacodynamic modeling, have become an essential component in the clinical phases of …
pharmacodynamic modeling, have become an essential component in the clinical phases of …
Dose Optimization in Oncology Drug Development: An International Consortium for Innovation and Quality in Pharmaceutical Development White Paper
D Samineni, K Venkatakrishnan… - Clinical …, 2024 - Wiley Online Library
The landscape of oncology drug development has witnessed remarkable advancements
over the last few decades, significantly improving clinical outcomes and quality of life for …
over the last few decades, significantly improving clinical outcomes and quality of life for …
[HTML][HTML] Moving the needle for oncology dose optimization: A call for action
K Venkatakrishnan, P Jayachandran… - CPT …, 2024 - ncbi.nlm.nih.gov
Project Optimus is a major FDA initiative aimed at ensuring dose optimization in oncology
drug development, moving away from the maximum tolerated dose paradigm and …
drug development, moving away from the maximum tolerated dose paradigm and …