Document Detail


Modeling and simulation for medical product development and evaluation: highlights from the FDA-C-Path-ISOP 2013 workshop.
MedLine Citation:
PMID:  25288257     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
Medical-product development has become increasingly challenging and resource-intensive. In 2004, the Food and Drug Administration (FDA) described critical challenges facing medical-product development by establishing the critical path initiative [1]. Priorities identified included the need for improved modeling and simulation tools, further emphasized in FDA's 2011 Strategic Plan for Regulatory Science [Appendix]. In an effort to support and advance model-informed medical-product development (MIMPD), the Critical Path Institute (C-Path) [ www.c-path.org ], FDA, and International Society of Pharmacometrics [ www.go-isop.org ] co-sponsored a workshop in Washington, D.C. on September 26, 2013, to examine integrated approaches to developing and applying model- MIMPD. The workshop brought together an international group of scientists from industry, academia, FDA, and the European Medicines Agency to discuss MIMPD strategies and their applications. A commentary on the proceedings of that workshop is presented here.
Authors:
Klaus Romero; Vikram Sinha; Sandra Allerheiligen; Meindert Danhof; Jose Pinheiro; Naomi Kruhlak; Yaning Wang; Sue-Jane Wang; John-Michael Sauer; J F Marier; Brian Corrigan; James Rogers; H J Lambers Heerspink; Tawanda Gumbo; Peter Vis; Paul Watkins; Tina Morrison; William Gillespie; Mark Forrest Gordon; Diane Stephenson; Debra Hanna; Marc Pfister; Richard Lalonde; Thomas Colatsky
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2014-10-7
Journal Detail:
Title:  Journal of pharmacokinetics and pharmacodynamics     Volume:  -     ISSN:  1573-8744     ISO Abbreviation:  J Pharmacokinet Pharmacodyn     Publication Date:  2014 Oct 
Date Detail:
Created Date:  2014-10-7     Completed Date:  -     Revised Date:  2014-10-8    
Medline Journal Info:
Nlm Unique ID:  101096520     Medline TA:  J Pharmacokinet Pharmacodyn     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
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