|Module Title||MEDC0056 Advanced Clinical Pharmacology and Therapeutics|
|Short Description||Based on case studies and hands-on group activities, this module provides students the further understanding of the regulatory and clinical requirements for an effective development program.|
The use of quantitative pharmacology methods and real world data are introduced as a tool for evidence synthesis and personalisation of treatment.
|Module Aims and Objectives|
The course is aimed at demonstrating how clinical pharmacology concepts can be applied in drug development and therapeutics to:
1) support evidence generation whilst addressing clinical and regulatory requirements (EMA, FDA, ICH)
2) optimise trial design (endpoint, inclusion/exclusion criteria) and
3) assess the relevance of personalised regimens in special populations or minorities, for whom a clinically benefit-risk balance differs from the overall target patient population.
Attention will be given to the role of biomarkers and covariate factors as predictors of treatment response in clinical trials and during therapeutic use of a drug.
|Module Tutor||Professor Oscar Della Pasqua|