Using Modeling and Simulation to Select Dosages for Combination Therapies and New Indications

When: 09/11/2023 - 09/11/2023
Where: Maryland and Online
FDA Office of Clinical Pharmacology and International Society of Pharmacometrics (ISoP) Public Workshop

The meeting will be held as a hybrid event, hosted from the Gaylord National Resort and Convention Center in National Harbor, Maryland, on November 9, 2023, 8:00am-4:45pm.

Goals and Objectives:

  • To discuss best practices and methods to incorporate quantitative methods into the clinical development of oncologic products as a means to support dosage optimization that has been strongly advocated for in recent engagements.
  • To describe the impact of dosage exploration on the benefit/risk assessment for oncologic drugs and highlight ongoing efforts from regulatory agencies, academic centers, and industry to shift current practices used to select dosages for investigation in clinical trials and identify the recommended dosage for marketing applications and labeling.
  • To discuss development of investigational and approved drugs in new combination or disease setting using model-based approaches to select, support and investigate dosing regimen(s).

More info and registration HERE


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