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Industry Perspective on Using MIDD for Pediatric Studies Requiring Integration of Ontogeny
Author(s) -
CorriolRohou Solange,
Cheung S. Y. Amy
Publication year - 2019
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1002/jcph.1495
Subject(s) - center of excellence , perspective (graphical) , excellence , food and drug administration , drug development , ontogeny , regulatory science , knowledge management , engineering ethics , business , computer science , medicine , political science , drug , risk analysis (engineering) , pharmacology , engineering , pathology , database , artificial intelligence , law
Joining the Food and Drug Administration/University of Maryland Center of Excellence in Regulatory Science and Innovation Workshop to discuss and identify solutions to optimize pediatric drug development and, in particular, to address the question as to whether we are ready to incorporate pediatric ontogeny into modeling was the opportunity to share learnings, confront ideas, and present examples of studies performed in industry and academia. This was not only the opportunity to reflect on the experience and the knowledge so far within the current regulatory framework but also to look at the future and explore new and future approaches as well as best practices with the use of modeling and simulation and extrapolation as part of pediatric development.