Modeling and Simulation at the Interface of Nonclinical and Early Clinical Drug Development | Zendy

Visser SAG | Zendy; Manolis E | Zendy; Danhof M | Zendy; Kerbusch T | Zendy

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Modeling 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

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