Verifying and Validating Quantitative Systems Pharmacology and < /i>In Silico< //i> Models in Drug Development: Current Needs, Gaps, and Challenges

Musuamba, Flora T; Bursi, Roberta; Manolis, Efthymios; Karlsson, Kristin; Kulesza, Alexander; Courcelles, Eulalie; Boissel, Jean-Pierre; Lesage, Raphaelle; Crozatier, Cecile; Voisin, Emmanuelle M; Rousseau, Cecile F; Marchal, Thierry; Alessandrello, Rossana; Geris, Liesbet

doi:10.1002/psp4.12504

Verifying and Validating Quantitative Systems Pharmacology and < /i>In Silico< //i> Models in Drug Development: Current Needs, Gaps, and Challenges

Author:

Musuamba, Flora T

Bursi, Roberta ; Manolis, Efthymios ; Karlsson, Kristin ; Kulesza, Alexander ; Courcelles, Eulalie ; Boissel, Jean-Pierre ; Lesage, Raphaelle ; Crozatier, Cecile ; Voisin, Emmanuelle M ; Rousseau, Cecile F ; Marchal, Thierry ; Alessandrello, Rossana ; Geris, Liesbet

Keywords:

Science & Technology, Life Sciences & Biomedicine, Pharmacology & Pharmacy, Computer Simulation, Drug Development, Humans, Models, Biological, Pharmacology, Systems Biology, Validation Studies as Topic, 1115 Pharmacology and Pharmaceutical Sciences, 1116 Medical Physiology, 3208 Medical physiology, 3214 Pharmacology and pharmaceutical sciences

Abstract:

The added value of in silico models (including quantitative systems pharmacology models) for drug development is now unanimously recognized. It is, therefore, important that the standards used are commonly acknowledged by all the parties involved. On April 25 and 26, 2019, a multistakeholder workshop on the validation challenges for in silico models in drug development was organized in Belgium. As an outcome, a White Paper is foreseen in 2020 on standards for in silico model verification and validation.