Zdrowie i gospodarka · 11.02.2014
Application of Physiologically-Based Pharmacokinetic Modeling To Support Dose Selection; Notice of Public Workshop; Request for Comments
The Food and Drug Administration (FDA or the Agency) is announcing a public workshop entitled "Application of Physiologically- Based Pharmacokinetic (PBPK) Modeling to Support Dose Selection." The purpose of the workshop is to obtain input on scientific approaches for the conduct and assessment of physiologically-based pharmacokinetic (PBPK) modeling within the framework of drug development and regulatory decisionmaking. The input from the workshop may be used to refine FDA's thinking on the various applications of PBPK. Preliminary elements of a draft concept paper will be presented to facilitate discussion at this public workshop.