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Event Title
FDA/CDER Office of Clinical Pharmacology and International Society of Pharmacometrics (ISoP) Public Workshop: Using Modeling and Simulation to Evaluate the Effects of Intrinsic and Extrinsic Factors
October 16, 2023

Date:
October 16, 2023
Time:
10:00 AM - 4:30 PM ET

Workshop Recording

 

About

The meeting was held October 16, 2023 as a Hybrid event, hosted from the FDA White Oak campus, 10:00am-4:30pm.

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 products 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 the role of model-based approaches in investigating how various intrinsic and extrinsic factors can influence the investigation and selection of a dosage(s) during clinical development.

Who Should Attend

This workshop is intended for interested parties regarding ongoing efforts; parties interested in continued advocacy for alternatives to traditional dose finding for oncologic drugs. The primary audience includes, clinical pharmacologists, pharmacometricians, pharmacologists/toxicologists, clinicians/healthcare providers, statisticians, patients, and patient advocates.

Meeting Materials

Contact

ISoP:

Jennifer Pastore Monroy, CAE
Executive Director, International Society of Pharmacometrics
jennifer.monroy@go-isop.org
Bridgewater, NJ 08807

FDA/CDER:

Bernadette Johnson-Williams, DHSc, MEd
Office of Clinical Pharmacology/OTS/CDER
bernadette.johnson-williams@fda.hhs.gov
Silver Spring, MD 21029

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