- funded by IMI-JU
- 01 March 2011 - 31 August 2016
- 11 EFPIA members
- 10 Academia and 5 SME's
- Total cost € 23,032,609
Model-informed drug discovery and development online course to illustrate the principles of cardiac safety in drug discovery and development. This includes consideration on preclinical, translational, clinical, regulatory expectation and modeling and simulation prospectives.
A hands-on exercise on translating preclinical QT interval (QTc) data from dogs to phase I clinical outcome in humans using pharmacokinetic–pharmacodynamic (PKPD) analysis for evaluation of Cardiac Safety risks using DDMoRe platform is available.
Model used: (Parkinson et al. J Pharmacol Toxicol Methods 2013)
Material extracted from the DDMoRe face-to-face course “Cardiac Safety”
Authors of the original exercise
Joanna Parkinson, AstraZeneca
Linea Bergenholm, AstraZeneca
Cecilia Arfvidsson, AstraZeneca
Amy Cheung, AstraZeneca
Niklas Hartung, Freie Universitaet Berlin
Authors of online training material
Zinnia Parra-Guillen, Universidad de Navarra
Amy Cheung, AstraZeneca