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

https://www.fda.gov/news-events/fdacder-office-clinical-pharmacology-and-international-society-pharmacometrics-isop-public-workshop?utm_medium=email&utm_source=govdelivery On October 16, 2023, the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Office of Clinical Pharmacology (OCP) in collaboration with the International Society of Pharmacometrics (ISoP) will hold a hybrid public workshop entitled Using Modeling and Simulation to Evaluate the Effects of Intrinsic and Extrinsic Factors. The workshop will examine how various intrinsic and extrinsic factors can influence the investigation and selection of dosages during clinical development. Workshop 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 dosages during clinical development Date/Time of the Workshop: Date: October 16, 2023 Time: 10:00am-4:30pm ET The primary audience includes clinical pharmacologists, pharmacometricians, pharmacologists/toxicologists, clinicians/healthcare providers, statisticians, patients, and patient advocates. This hybrid event is open to the public with no cost to attend; however, registration is required. More information about this event can be found here.