This module is about the process of turning basic biological research into an end product e.g. a drug, licenced for clinical use. Stages of the process discussed include drug design, pharmacodynamics to identify efficacy, pharmacokinetics and clinical trials. The essential roles of process management and quality by design in meeting the demands of regulatory bodies will be introduced.
The aim of this module is to provide students with a detailed understanding of the pre-clinical and clinical stages of drug development.
By the end of this module the student should be able to:
1. Critically discuss the process of drug development from drug target identification and basic pharmacology to product development and licensing.
2. Evaluate clinical trial data and understand the basis of clinical trial design.
3. Understand the importance of the link between knowledge and management of a process and the quality and successful licencing of the final product.
1 Process and quality management
Process and quality management as key themes throughout drug development: Good laboratory practice, good clinical practice and good manufacturing practice. The role of Quality by Design, Regulatory Affairs and quality assurance in drug licencing. The role of MHRA and FDA, etc.
2 Identifying and developing candidate drug molecules
Examining clinical drivers, QSAR, high-throughput-screening, intellectual property.
3 Cellular structures as drug targets
Cellular structures as drug targets focusing mainly on cell surface receptors: Pharmacodynamics of drug-receptor binding. Quantifying drug efficacy and binding in vitro.
4 Preclinical development
Pharmacokinetics, toxicity studies in animal models.
5 Clinical Trials
Clinical Trials Good Clinical Practice, Phase I to IV of clinical trials. Study design trial, sources of bias, recruitment, and sample size, analysis of data Per-protocol/intention to treat analysis.
6 Guest Lecturer from Industry
Product development and marketing
7 Large scale manufacturing
Large scale manufacturing, Regulatory approval, post market monitoring (Phase (IV)
Statement on Teaching, Learning and Assessment
Lecture material will be delivered as a series of short (15mins) online presentations with associated Blackboard self-assessment exercises (MCQs and calculations). These will be completed by the student as independent study and by specified deadlines to ensure that the student is prepared for the practical classes. Student progress and participation will be monitored via Blackboard. Practical classes will concentrate on a series of exercises that will test understanding of the on-line material and consolidate learning. Typical exercises include using simulation software to quantify the dissociation constant of a drug, designing a clinical trial and analysing and interpreting data. Students may be asked to research in groups and present on topics such as the pharmacokinetics or manufacture of a commonly prescribed drug. At all points students will be encouraged to view individual exercises as elements within a larger process each introducing sources of variation and quality issues.
Teaching and Learning Work Loads
|Supervised Practical Activity||24|
|Unsupervised Practical Activity||0|
Credit Value – The total value of SCQF credits for the module. 20 credits are the equivalent of 10 ECTS credits. A full-time student should normally register for 60 SCQF credits per semester.
We make every effort to ensure that the information on our website is accurate but it is possible that some changes may occur prior to the academic year of entry. The modules listed in this catalogue are offered subject to availability during academic year 2018/19 , and may be subject to change for future years.