[ascct] FDA Wkshp: application of PBPK modeling to support dose selection
- From: Kristie Sullivan <KSullivan@xxxxxxxx>
- To: "ascct@xxxxxxxxxxxxx" <ascct@xxxxxxxxxxxxx>
- Date: Tue, 11 Feb 2014 09:35:00 -0500
http://www.gpo.gov/fdsys/pkg/FR-2014-02-11/html/2014-02883.htm
SUMMARY: 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.
DATES: The workshop will be held on March 10, 2014, from 8:30 a.m. to
4:30 p.m. Individuals who wish to attend the workshop must register by February
24, 2014. Please submit either electronic or written comments by April 10,
2014, to receive consideration.
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- » [ascct] FDA Wkshp: application of PBPK modeling to support dose selection - Kristie Sullivan
