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MEDC0056 Advanced Clinical Pharmacology and Therapeutics

Module TitleMEDC0056 Advanced Clinical Pharmacology and Therapeutics
Module Value15
TermTerm 2
Short DescriptionBased 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.

 Topics
  • Introduction to therapeutics and personalised medicine
  • Biomarkers in clinical drug development and therapeutics
  • Trial design and dose rationale for first-time-in-humans and proof-of-concept
  • Trial design and dose rationale for phase IIb and III studies
  • Trial design and dose rationale in special populations
  • Regulatory requirements for filing of an MAA or NDA
  • Understanding drug response in real-life: clinical trial simulations
  • Dosing algorithms and prescription practice
Assessment details
  • 2,000 word individual report (25%)
  • 15 minute Group oral presentation (15%)
  • 1 hour Multiple Choice Questionnaire Examination (60%)
 Module TutorProfessor Oscar Della Pasqua