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Curricular information is subject to change
On successful completion of this module students should be able to:
-Describe the development process from discovery of a molecule to administration as a medicine to patients
-Be able to discuss rational drug design and high throughput screening in Discovery
-Assess pharmacokinetic studies in working out doses and tissue target concentrations
-What are the safety requirements needed before a drug can be approved?
-Cite clinical trial case studies of recent drugs that have been approved for major diseases
-Cite examples of drug delivery technologies for non-injected delivery of biotech molecules
-Know the requirements and outputs examined for clinical trials in Phases 1-4
-Be able to write an essay on attrition causes in clinical development and possible remedies
-Understand how biomarkers can be used in Development
-How prodrugs of small molecules can be used to improve pharmacokinetic profiles
This module covers all the elements that go into a discovery programme for a new chemical entity along with its development in going from a lead to a hit. From preclinical studies in animals and cells covering toxicology and the processes of pharmacokinetics and pharmacodynamics, we then move into the clinical development phases, right through to FDA approval. We saw that in 2022 the clinical development process is flexible and can be expedited by parallel rather than linear movement between clinical phases where the next stage can start without full reporting of the current phase. This can be accompanied by review at breakneck speed by the Regulators in an emergency pandemic - this can allow emergency use of essential drugs and vaccines.
Student Effort Type | Hours |
---|---|
Lectures | 12 |
Autonomous Student Learning | 90 |
Total | 102 |
Ideally, students should be familiar with basic pharmacokinetics and pharmacodynamics to get the most from the module. However, we will do some recapping in the event that there are attendees from non-pharmacology backgrounds.
Learning Recommendations:Biomedical undergraduate modules in pharmacology, biochemistry and physiology taught in science, medicine or veterinary to 3rd year level. Undergraduate chemists with an interest in the drug development process would be welcome. MSc students in Biotechnology are welcome to attend. Undergrad medicinal chemists are especially welcome and usually achieve good outcomes.
Resit In | Terminal Exam |
---|---|
Summer | Yes - 2 Hour |
• Feedback individually to students, post-assessment
Exam writing guide to be presented to students ahead of exam. Going over scripts post-exam with individual students. Availability to meet students ahead of exam.
Name | Role |
---|---|
Professor Orina Belton | Lecturer / Co-Lecturer |
Professor David Brayden | Lecturer / Co-Lecturer |
Dr Colm Collins | Lecturer / Co-Lecturer |
Dr Fiona McCartney | Lecturer / Co-Lecturer |
Dr Ena Prosser | Lecturer / Co-Lecturer |
Lecture | Offering 1 | Week(s) - 20, 21, 22 | Thurs 09:00 - 09:50 |
Lecture | Offering 1 | Week(s) - 23 | Thurs 09:00 - 09:50 |
Lecture | Offering 1 | Week(s) - 20, 21, 22, 23 | Tues 09:00 - 09:50 |
Lecture | Offering 1 | Week(s) - 20, 21, 22, 23 | Wed 14:00 - 14:50 |