Benefits of using modeling and simulation in drug development

Check out this video...a very nice illustration of how clinical pharmacologists use PKPD to influence decision making during drug development.

Cancer Drug Costs

 Interesting read on a review of cancer drug costs by ASCO.

Cost of Developing a New Drug

Oncology and Dose Finding

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