Earlier this year, US FDA and AACR cosponsored a public workshop titled “Dose-finding of Small Molecule Oncology Drugs.” There were several interesting presentations and recommendations on how we can optimize the dose and dosing schedule during development. As in other therapeutic . areas, dose finding studies are usually not conducted during oncology drug development and the dose for phase 2/3 studies is typically based on MTD and PKPD data from limited patients in the dose escalation trial.
The goal was to promote a movement away from conventional dose escalation trial design and move toward innovative designs that can incorporate key clinical, pharmacologic, pharmacometric data, and when appropriate, non-clinical information to guide dose selection.
Check out the agenda, slides and recorded presentation at Dose-finding of Small Molecule Oncology Drugs
The goal was to promote a movement away from conventional dose escalation trial design and move toward innovative designs that can incorporate key clinical, pharmacologic, pharmacometric data, and when appropriate, non-clinical information to guide dose selection.
Check out the agenda, slides and recorded presentation at Dose-finding of Small Molecule Oncology Drugs
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