Open AccessModeling and Simulation at the Interface of Nonclinical and Early Clinical Drug Development
Author(s) -
Visser SAG,
Manolis E,
Danhof M,
Kerbusch T
Publication year - 2013
Publication title -
cpt: pharmacometrics and systems pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.53
H-Index - 37
ISSN - 2163-8306
DOI - 10.1038/psp.2013.3
Subject(s) - drug development , session (web analytics) , pharmacology , agency (philosophy) , drug , operations research , medicine , computer science , engineering , sociology , world wide web , social science
The role of modeling and simulation (M&S) in early drug development was discussed in a break out session of the European Medicines Agency/European Federation of Pharmaceutical Industries and Associations (EMA/EFPIA) M&S workshop held in December 2011 in London, UK. The discussions were focused on two themes: (i) M&S in nonclinical and early clinical drug development and (ii) M&S for first‐in‐human (FIH) dose selection. Illustrative case studies were presented and links are listed in Table 1. Common objectives and next steps were identified, discussed, and agreed. CPT: Pharmacometrics & Systems Pharmacology (2013) 2, e30; doi: 10.1038/psp.2013.3 ; advance online publication 27 February 2013