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DEGREE REGULATIONS & PROGRAMMES OF STUDY 2015/2016

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DRPS : Course Catalogue : Deanery of Molecular, Genetic and Population Health Sciences : Molecular and Clinical Medicine

Postgraduate Course: Translational Pharmacology (MCLM11009)

Course Outline
SchoolDeanery of Molecular, Genetic and Population Health Sciences CollegeCollege of Medicine and Veterinary Medicine
Credit level (Normal year taken)SCQF Level 11 (Postgraduate)
Course typeOnline Distance Learning AvailabilityNot available to visiting students
SCQF Credits10 ECTS Credits5
SummaryFirst-in-Human trials are the first major stage in the clinical testing process. These trials are primarily concerned with assessing a drug┐s safety and tolerability, and provide the first steps in testing new investigational medicines in humans. This module is designed to allow candidates to develop an understanding of Phase 1 clinical studies with the specific emphasis on areas of design, conduct and analysis. Whether conducted in healthy or patient volunteers, the primary end-points are tolerability, pharmacokinetics, and evidence of drug effects on biomarkers of efficacy and safety. Candidates will also gain an up-to-date knowledge of the scientific basis of drug action. Translational Pharmacology will provide an understanding of preclinical science, ethical and legal requirements for clinical research projects and how to design and interpret clinical trials.
Course description Not entered
Entry Requirements (not applicable to Visiting Students)
Pre-requisites Co-requisites
Prohibited Combinations Other requirements None
Course Delivery Information
Academic year 2015/16, Not available to visiting students (SS1) Quota:  None
Course Start Semester 1
Timetable Timetable
Learning and Teaching activities (Further Info) Total Hours: 100 ( Seminar/Tutorial Hours 5, Online Activities 100, Feedback/Feedforward Hours 40, Formative Assessment Hours 12, Summative Assessment Hours 10, Revision Session Hours 8, Programme Level Learning and Teaching Hours 2, Directed Learning and Independent Learning Hours 0 )
Assessment (Further Info) Written Exam 0 %, Coursework 100 %, Practical Exam 0 %
Additional Information (Assessment) Online participation: 25%
Individual project: 25%
Reflective portfolio: 30%
Case scenarios: 20%
Feedback Not entered
No Exam Information
Learning Outcomes
On completion of this course, the student will be able to:
  1. Evaluate from preclinical data whether a new medicinal product can be safely taken into human studies for the first time
  2. Obtain appropriate legal and ethical approval for a Phase 1 study
  3. Conduct a Phase 1 clinical trial
  4. Interpret and explain the clinical data received from Phase 1 clinical studies and plan the next course of action
Reading List
None
Additional Information
Graduate Attributes and Skills Not entered
KeywordsFirst-in-human, safety, efficacy, tolerability, study design, pharmacokinetics, pharmacodynamics, pr
Contacts
Course organiserMiss Michelle Evans
Tel: 0131 537 3326
Email: michelle.evans@ed.ac.uk
Course secretaryMrs Danielle Marlow
Tel: 0131 537 3798
Email: Danielle.Wilson@ed.ac.uk
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