Postgraduate Course: Translational Pharmacology (MCLM11009)
Course Outline
| School | School of Molecular, Genetic and Population Health Sciences |
College | College of Medicine and Veterinary Medicine |
| Course type | Online Distance Learning |
Availability | Not available to visiting students |
| Credit level (Normal year taken) | SCQF Level 11 (Postgraduate) |
Credits | 10 |
| Home subject area | Molecular and Clinical Medicine |
Other subject area | None |
| Course website |
None |
Taught in Gaelic? | No |
| Course description | First-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. |
Entry Requirements (not applicable to Visiting Students)
| Pre-requisites |
|
Co-requisites | |
| Prohibited Combinations | |
Other requirements | None |
| Additional Costs | None |
Course Delivery Information
|
| Delivery period: 2013/14 Semester 1, Not available to visiting students (SS1)
|
Learn enabled: Yes |
Quota: None |
Web Timetable |
Web Timetable |
| Course Start Date |
16/09/2013 |
| Breakdown of 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 )
|
| Additional Notes |
|
| Breakdown of Assessment Methods (Further Info) |
Written Exam
0 %,
Coursework
100 %,
Practical Exam
0 %
|
| 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 |
Assessment Information
Online participation: 25%
Individual project: 25%
Reflective portfolio: 30%
Case scenarios: 20% |
Special Arrangements
| None |
Additional Information
| Academic description |
Not entered |
| Syllabus |
Not entered |
| Transferable skills |
Not entered |
| Reading list |
Not entered |
| Study Abroad |
Not entered |
| Study Pattern |
Not entered |
| Keywords | First-in-human, safety, efficacy, tolerability, study design, pharmacokinetics, pharmacodynamics, pr |
Contacts
| Course organiser | Miss Michelle Evans
Tel: 0131 537 3326
Email: michelle.evans@ed.ac.uk |
Course secretary | Mrs Danielle Marlow
Tel: 0131 537 3798
Email: Danielle.Wilson@ed.ac.uk |
|
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