MEDCG017 Clinical Pharmacology and Therapeutics

Module Title
MEDCG017 Clinical Pharmacology and Therapeutics
Module Value
15
Term
Term 2
Short Description

Theoretical concepts on pharmacokinetics and pharmacodynamics as well as their implications for the safety and efficacy of medicines.

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.
 Topics
  • Principles of translational research and its role in drug development.
  • Requirements for early exploratory development in man.
  • Factors determining variability in clinical response
  • 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.
Assessment details
  • 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

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