Postgraduate Course: Translational Pharmacology (MCLM11073)
Course Outline
| School | Deanery of Molecular, Genetic and Population Health Sciences |
College | College of Medicine and Veterinary Medicine |
| Credit level (Normal year taken) | SCQF Level 11 (Postgraduate) |
| Course type | Online Distance Learning |
Availability | Not available to visiting students |
| SCQF Credits | 20 |
ECTS Credits | 10 |
| Summary | Healthcare professionals will develop a thorough understanding of early phase clinical studies with specific emphasis on the areas of design, conduct and analysis of 'first-in-human' and other exploratory studies of investigational medicinal products (IMPs). 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. Students will also gain an up-to-date knowledge of the scientific basis of drug action.
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| Course description |
Translational pharmacology is the application of biomedical research, conducted to support drug development, which aids in patient selection, dosing regimen and segmentation of diseases. It is based on the concept - known as 'Bench to Bedside' - of translating laboratory findings into the clinic i.e. patient care, for achieving better patient treatment. Early phase (First-in-Human and Phase 1) trials are the initial 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 course is designed to develop students' understanding of early phase clinical studies with the specific emphasis on areas of design, conduct and analysis. Whether trials are conducted in healthy or patient volunteers, the primary end-points are tolerability, pharmacokinetics, and evidence of drug effects on biomarkers of efficacy and safety. Students 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 early phase clinical trials.
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Entry Requirements (not applicable to Visiting Students)
| Pre-requisites |
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Co-requisites | |
| Prohibited Combinations | |
Other requirements | None |
Course Delivery Information
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| Academic year 2022/23, Not available to visiting students (SS1)
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Quota: None |
| Course Start |
Flexible |
Timetable |
Timetable |
| Learning and Teaching activities (Further Info) |
Total Hours:
200
(
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 4,
Directed Learning and Independent Learning Hours
21 )
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| Assessment (Further Info) |
Written Exam
0 %,
Coursework
100 %,
Practical Exam
0 %
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| Additional Information (Assessment) |
Contribution to discussion boards - 20%
Written assignment (Individual project I): 35%
Written assignment (Individual project II) : 45%
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| Feedback |
Not entered |
| No Exam Information |
Learning Outcomes
On completion of this course, the student will be able to:
- Apply the principles behind analysis and evaluation of preclinical data and the decision process behind taking a new medicinal product safely into humans for the first time
- Explain how to obtain appropriate legal and ethical approval for a Phase 1 study
- Explain and apply the principles and methods in the process of conducting early phase clinical trials
- Critically assess and evaluate the clinical data received from early phase clinical studies and determine the next course of action
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Additional Information
| Graduate Attributes and Skills |
Within the work to be undertaken this course will provide course participants with the opportunity to develop or further develop key graduate attributes:
- In-depth knowledge of specialist discipline
- Develop new understanding by exercising critical judgement and challenging knowledge
- Be a self-directed and curious learner
- Solve problems effectively taking ethical, professional and environmental issues into account
- Use information responsibly in a range of contexts
- Engage in reflective practice and self-development
- Collaborate with others, capitalising on their different thinking, experience and skills
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| Keywords | Translational Pharmacology,First-in-human,Phase I,safety,efficacy,tolerability,study design |
Contacts
| Course organiser | Dr James Dear
Tel: (0131) 242 9214
Email: |
Course secretary | Mr David Stevens
Tel: 0131 242 6120
Email: |
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