|Module Title||MEDC0055 Clinical Pharmacology and Therapeutics|
This module provides an overview of the theoretical concepts on pharmacokinetics and pharmacodynamics as well as their implications for the dose rationale and subsequent evaluation of safety and efficacy of medicines in humans.
|Module Aims and Objectives|
- The course is aimed at identifying the determinants of pharmacological response and variability in humans.
- Focus will be given to the relationship between drug delivery, pharmacokinetics, signal transduction, homeostasis, disease progression and treatment outcome.
- Based on real-life examples, this module provides students the clinical pharmacological basis for dose and patient selection during clinical development and therapeutic evaluation of novel medicines.
- In addition, quantitative pharmacology methods are introduced as a tool for translational research, study design optimisation and dosing recommendation in special populations.
- Principles of translational research and its role in drug development.
- Requirements for early exploratory development in humans.
- Factors determining variability in clinical response (e.g., drug-drug interactions, food-drug interaction, polymorphisms)
- Practical application of pharmacokinetics and pharmacodynamics as biomarkers in drug development
- Choice and predictive value experimental and mathematical models as part of the overall drug development plan for small molecules and biologicals
- Clinical trial simulations and quantitative methods for study design optimization.
- 2,000 word Group report (30%)
- 15 minute Group oral presentation (20%)
- 1 hour Multiple Choice Questionnaire Examination (50%)
| Module Tutor||Professor Oscar Della Pasqua|