Mark your calendars for Innovative Approaches to Pediatric Drug Development and Pediatric Medical Countermeasures: A Role for Physiologically-Based PK?, a conference sponsored by the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) and the Food and Drug Administration (FDA), and a collaboration between M-CERSI and the American College of Clinical Pharmacology (ACCP).
About the Event:
Understanding drug disposition and elimination in pediatric populations, especially neonates and infants, is a challenging problem that requires a clear understanding of the dynamic interplay between pediatric growth and development, maturation of processes involved in drug metabolism and elimination, disease effects, and intrinsic properties of the drug. Physiologically-based pharmacokinetic (PBPK) modeling provides a platform that could account for these processes to predict pharmacokinetic properties and assist with devising pediatric development strategies.
Join scientists from industry, academia, and regulatory agencies on Monday, May 5, 2014, from 8:30 a.m. to 5:00 p.m. at the Food and Drug Administration's (FDA) White Oak Campus, located at 10903 New Hampshire Avenue in Silver Spring, MD, as they share their experiences and discuss best practices for PBPK in pediatric drug development and pediatric medical countermeasures.
In addition to reviewing current practices and application of pediatric PBPK modeling from industry, academia, and FDA, this workshop will define demonstrated and potential limitations and advantages of PBPK in pediatric drug development, with special attention to medical countermeasures, and assess the utility of the current PBPK methodologies and specialized software for PBPK modeling in pediatric drug development.
About Sponsors and Collaborators:
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The Center of Excellence in Regulatory Science and Innovation (CERSI) focuses on modernizing and improving the ways in which drugs and medical devices are developed and evaluated. It is a collaborative partnership between the Food and Drug Administration (FDA) and the Baltimore and College Park campuses of the University of Maryland. |
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The American College of Clinical Pharmacology (ACCP) is a non-profit membership association with a more than 40 year history of providing exceptional interdisciplinary, accredited continuing education programs, publications, networking, and other career-enhancing opportunities to a wide spectrum of health care professionals using clinical pharmacology in disciplines from research to patient care. |
For More Information:
More information -- including an agenda and registration, as well as information about the White Oak Campus -- can be found on this website.