Advisory Committee for Pharmaceutical Science and Clinical Pharmacology
Meeting on March 14, 2012, from 7:30 a.m. to 3 p.m.
Agenda: The committee will discuss the clinical pharmacology aspects of pediatric clinical trial design and dosing to optimize pediatric drug development. FDA will seek input on how to strategically inform pediatric clinical trial design and dosing by utilizing existing knowledge, including available adult and nonclinical data. The discussion will include the role of modeling and simulation including physiologically-based pharmacokinetic modeling in pediatric drug development. Modeling and simulation is the application of mathematical approaches to predicting what will happen in a clinical trial with pediatric patients when a particular dose of a drug is used.
Subscribe to:
Post Comments (Atom)
No comments:
Post a Comment