Bridging Drug Efficacy and Safety to the Obese: Considerations and Scientific Approaches

Besides the major health and socioeconomic implications of obesity, there are great challenges in ensuring the optimal use and development of drugs for the growing population of obese persons. Obese patients are a large segment of the U.S. population and should be included in drug development studies. There are presently no clear dosing guidelines for obese pediatric patients. Although smaller clinical studies have begun to examine drug PK in obese pediatric patients, the relationship between pediatric obesity and drug response, including efficacy and safety, has not been thoroughly elucidated. Advancing this field requires identifying key knowledge gaps and barriers to conduct of such studies and potential innovative solutions to improve data generation and analysis.  

Meeting Objectives:

1. Review the implications of obesity in adult and pediatric patients on safety, efficacy, drug dosing and disposition

2. Discuss:

(a) if adult and pediatric patients should be identified and studied as a special population in new drug development programs.

(b) when it may be appropriate to include obese patients in drug development studies to develop specific dosing guidelines for obese patients.

The event agenda is available online.

This workshop was supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award U01FD005946 with 100 percent funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.