2022/23 Taught Postgraduate Module Catalogue

BMSC5120M Drug Development: Pre-clinical

15 creditsClass Size: 40

Module manager: Dr Al Pickles
Email: a.r.pickles@leeds.ac.uk

Taught: Semester 1 (Sep to Jan) View Timetable

Year running 2022/23

Pre-requisite qualifications

none

This module is not approved as an Elective

Module summary

The module will provide an outline to the principles and methods involved in a range of preclinical models used in drug development. There will be an emphasis on understanding of the practical application of these models by the detailed analysis of real examples backed up with the relevant theory to enable an understanding of how and why they are used. It will expand and develop on some of the aspects introduced in the complementary module reproducibility and reliability of pre-clinical animal models’, providing specific drug development examples employing principles covered in that module. The module will also provide an overview of the stages involved in the progression of a drug through the drug development pipeline and will include a range of external speakers from relevant area of that process to give a sound and comprehensive overview.

Objectives

The objectives are to provide a broad yet detailed understanding of the various approaches and techniques applied in preclinical drug development including the efficacy and safety/toxicity testing of novel compounds prior to first time in man (clinical trials).

Learning outcomes
On completion of this module students should, through a research plan and annotated bibliography, evidence their knowledge and understanding of the following:
1. The many stages animal models are used in preclinical drug development;
2. The range of animal models used in the testing of novel drugs;
3. The theories and rationale of the use of animals in drug development including considerations of the requirements of different species;
4. Specific preclinical methods employed in efficacy testing;
5. Specific preclinical methods employed in safety pharmacology and toxicological testing.

Syllabus

- Preclinical efficacy testing in animals.
- In-vivo DMPK.
- Safety pharmacology including non-clinical abuse liability.
- Toxicological screening including cancer biology testing.
- Non-mammalian or embryonic alternatives & future directions.
- Example drugs and their route through development.
- Regulatory considerations including ICH /OECD guidelines.
- Input from relevant external speakers covering real-life application of methods and theory.

Teaching methods

Delivery type	Number	Length hours	Student hours
Lectures	10	1.00	10.00
Seminars	3	1.00	3.00
Tutorials	2	4.00	4.00
Private study hours			133.00
Total Contact hours			17.00
Total hours (100hr per 10 credits)			150.00

Private study

Students will be provided with essential content and information in workshops and screencasts. They will supplement this knowledge, as required from publicly available research and educational resources, and apply it, as a team, in the development of a research proposal for a preclinical research study.

Opportunities for Formative Feedback

Students will receive the formative feedback on a draft of their project.

Methods of assessment

Coursework

Assessment type	Notes	% of formal assessment
Group Project	A comprehensive research plan to assess the efficacy and safety of an assigned class of drug intended to treat a given disease.	60.00
Literature Review	Annotated Bibliography (10 papers)	40.00
Total percentage (Assessment Coursework)		100.00

Alternative resit will be required for any student that has not engaged and/or contributed to the generation of the group project. The resit would be expected to be of a similar approach however with an alternative focus of the central disease process.

Reading list

There is no reading list for this module

Last updated: 13/10/2022

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