The Role of Quantitative Systems Pharmacology in the Design of First-in-Human Trials

Author:

van der Graaf Piet H.12,Benson Neil2

Affiliation:

1. Leiden Academic Centre for Drug Research; University of Leiden; Leiden The Netherlands

2. Certara QSP; Canterbury Innovation Centre; Canterbury UK

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference5 articles.

1. Promoting safe early clinical research of novel drug candidates: a European Union regulatory perspective;Ponzano;Clin. Pharmacol. Ther.,2018

2. An industry perspective on the 2017 EMA guideline on first-in-human and early clinical trials;DeGeorge;Clin. Pharmacol. Ther.,2018

3. A systems pharmacology perspective on the clinical development of fatty acid amide hydrolase inhibitors for pain;Benson;CPT Pharmacometrics Syst. Pharmacol.,2014

4. Gandon , J.M. BIA 10-2474 accident: biotrial crisis management - facts, impact & lessons https://www.ascpt.org/Meetings/Past-Future-Annual-Meetings/ASCPT-2017/Saturday-March-18-Presentations

5. Activity-based protein profiling reveals off-target proteins of the FAAH inhibitor BIA 10-2474;Esbroeck;Science,2017

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