For some time now, cancer drug developers have known “Project Optimus” and new dose optimization expectations are coming their way from the Food and Drug Administration’s (FDA) Oncology Center of Excellence for Oncology Drugs… By Julie Bullock, PharmD
Clinical pharmacology gap analysis is a tool for outlining your drug program’s needs, prioritizing these needs, and providing a framework for how to satisfy them. This tool can create value for drug development programs. While gap analysis can be performed at any point in the drug development continuum, early engagement is best for maximizing its benefits. … Continued
