Computer Simulation/standards; Drug Development/methods; Humans; Models, Biological; Pharmacology; Systems Biology; Validation Studies as Topic
Disciplines :
Engineering, computing & technology: Multidisciplinary, general & others
Author, co-author :
Musuamba, Flora T; EMA Modelling and Simulation Working Party, Amsterdam, The Netherlands. ; Federal Agency for Medicines and Health Products, Brussels, Belgium. ; Faculté des Sciences Pharmaceutiques, Université de Lubumbashi, Lubumbashi, DR
Piñero, J., Furlong, L.I. & Sanz, F. In silico models in drug development: where we are. Curr. Opin. Pharmacol. 42, 111–121 (2018).
Madabushi, R. et al. The US Food and Drug Administration's model-informed drug development paired meeting pilot program: early experience and impact. Clin. Pharmacol. Ther. 106, 74–78 (2019).
The Report From the Expert Group on (Quantitative) Structure-Activity Relationships on the Principles for the Validation of (Q)SARs. Paris, France: Organization for Economic Co-operation and Development (OECD) Expert Group on QSARs (2004). Accessed December 19, 2019.
Committee for Medicinal Products for Human Use (CHMP). Guideline on reporting the results of population pharmacokinetic analysis . Accessed December 19, 2019.
US Food and Drug Administration (FDA). Exposure-response relationships — study design, data analysis, and regulatory applications. . Accessed December 19, 2019.
European Medicines Agency (EMA). Reflection paper on the use of extrapolation in the development of medicines for paediatrics . Accessed December 19, 2019.
European Medicines Agency (EMA). Guideline on the reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation . Accessed December 19, 2019.
US Food and Drug Administration (FDA). Physiologically based pharmacokinetic analyses — format and content guidance for industry . Accessed December 19, 2019.
The American Society of Mechanical Engineers (ASME). Assessing credibility of computational modeling through verification and validation: application to medical devices V V 40 – 2018. . Accessed December 19, 2019.
Kuemmel, C. et al. Consideration of a credibility assessment framework in model-informed drug development: potential application to physiologically-based pharmacokinetic modeling and simulation. CPT Pharmacometrics Syst. Pharmacol. 9, 21–28 (2020).
