Description
The course is aimed at demonstrating how clinical pharmacology concepts can be applied in drug development and therapeutics to 1) support evidence generation, 2) optimise trial design (endpoint, inclusion/exclusion criteria) and 3) assess the relevance of personalised regimens in special populations, for whom a clinically benefit-risk balance differs from the overall target patient population.
Attention is given to the role of biomarkers and covariate factors as predictors of treatment response in clinical trials and during therapeutic use of a medicinal product. This is complemented by an overview of their use in conjunction with innovative clinical trial designs. 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 deliveries for 2024/25 academic year
Last updated
This module description was last updated on 19th August 2024.
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