Should Obese Patients Be Included In Every Drug Development Program?

Experts from the US Food and Drug Administration, academia and industry did not reach a consensus on whether obese patients should be considered a specific population in new drug development studies but they agreed that they should be included in trials and that modeling tools might provide insights on whether a compound’s dosing and disposition is different in obese patients.

Panelists discussed how to bridge drug efficacy and safety to obese patients at a virtual workshop convened by the FDA and the University of Maryland Center of Excellence in Regulatory...