Open AccessReport from the EMA workshop on qualification and reporting of physiologically based pharmacokinetic (PBPK) modeling and simulation
Author(s) -
Zhao P
Publication year - 2017
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 - 10.1002/psp4.12166
Subject(s) - physiologically based pharmacokinetic modelling , guideline , agency (philosophy) , medical physics , pharmacokinetics , medicine , engineering ethics , pharmacology , management science , engineering , sociology , pathology , social science
On Nov 21, 2016, the European Medicines Agency (EMA) hosted a workshop to discuss its draft guideline on qualification and reporting of physiologically based pharmacokinetic (PBPK) analysis. 1 Published on July 21, 2016, the draft PBPK guideline is currently under the period of public comments.