Module manager: Dr David Lewis
Email: D.I.Lewis@leeds.ac.uk
Taught: Semester 2 (Jan to Jun) View Timetable
Year running 2026/27
This module is not approved as an Elective
This module will cover the “essentials” of the use of animals in preclinical drug development including national and international legislation, ethical issues and review processes, animal welfare and husbandry, and the critical role of animal welfare on the reproducibility, reliability and translatability of data from pre-clinical studies. It will consider the regulatory and other drivers for change in the global transition from animals to new approach methodologies and non-animal technologies in pre-clinical research. You will also gain hands-on experience of working with research animals, pre-clinical safety pharmacological, and other core regulatory approaches and techniques in research animals. It is designed to prepare students for careers in research, whether or not these involve animals, or careers in Pharma where knowledge of studies involving animals is advantageous.
The objectives of this module are to provide students with in-depth understanding and appreciation of the involvement of animal models in pre-clinical drug discovery and development, and the current regulatory and other drivers to ultimately replace animals with new approach methodologies and non-animal technologies. Content is applied in workshops, practical sessions, and in formative and summative assessments, to further develop understanding, research skills, and ethical and cultural awareness and values. Reflective logs consolidate this learning, and students personal and professional development.
On successful completion of the module students will be able to:
1. Appraise the legislative and regulatory frameworks governing the involvement of animals in research, and the differences in these across the world
2. Compare the ethical issues, including the principles of humane experimental technique, and contemporary ethical frameworks surrounding the involvement of research animals in pre-clinical drug discovery and development
3. Appraise animal welfare factors that influence the reproducibility, reliability, and translatability of pre-clinical drug discovery and development studies
4. Evaluate the involvement of animals compared to new approach methodologies and non-animal technologies in defined areas of pre-clinical drug discovery and development.
Skills Learning Outcomes
On successful completion of the module students will be able to:
5. Critically analyse, evaluate and interpret data from research animal studies
6. Design a scientifically robust, and legally and ethically permissible, programme of research which requires the use of research animals
7. Employ ethical and cultural awareness and capital
Experimental & project design; Creativity; Ethical awareness & responsibility; Experimental and technical skills; Service orientation.
| Delivery type | Number | Length hours | Student hours |
|---|---|---|---|
| On-line Learning | 11 | 1 | 12 |
| Seminars | 3 | 2 | 6 |
| Practicals | 2 | 2.5 | 5 |
| Practical | 1 | 3 | 3 |
| Independent online learning hours | 20 | ||
| Private study hours | 104 | ||
| Total Contact hours | 26 | ||
| Total hours (100hr per 10 credits) | 150 | ||
Student will be provided with essential content and information in workshops and screencasts. They will supplement this knowledge, as required from publically available research animal sciences educational resources, and apply it, as a team, in the development of an application to an animal ethics committee for a preclinical research study involving the use of research animals.
Formative feedback will be provided through workshops, module discussion boards and after each in-course assignment.
| Assessment type | Notes | % of formal assessment |
|---|---|---|
| Multimodal Assessment | Team creation of project licence application (40%) & individual defence (30%) | 70 |
| Report | Safety Pharmacology briefing note | 20 |
| Reflective log | Reflective log | 10 |
| Total percentage (Assessment Coursework) | 100 | |
The reflective log can not be repeated and will be replaced with a reflective essay.
Check the module area in Minerva for your reading list
Last updated: 30/04/2026
Errors, omissions, failed links etc should be notified to the Catalogue Team