2024/25 Undergraduate Module Catalogue

BMSC2238 Applied Concepts in Drug Development

20 Credits Class Size: 100

Module manager: Steven Clapcote
Email: S.J.Clapcote@leeds.ac.uk

Taught: Semester 2 (Jan to Jun) View Timetable

Year running 2024/25

Pre-requisite qualifications

First year of a programme in SBMS, or equivalent

Module replaces

BMSC2223

This module is not approved as a discovery module

Module summary

This module explores the preclinical and clinical processes involved in evaluating whether optimised lead compounds (or other drug types) are likely to be safe and efficacious as a drug. The preclinical stages include evaluating drug efficacy and ADME in in vitro assays and in vivo, in animal disease models. More recent developments have involved human stem cell-derived tissue models and the use of non-mammalian disease models. The module will also cover the stages of clinical trials. Learners will also acquire knowledge of the legal and regulatory aspects associated with the protection, marketing, and monitoring of a drug that has been approved for clinical use.

Objectives

This module aims to provide an understanding of Pharmacological concepts relating to the preclinical and clinical drug development process. The module will cover the different types of drug that enter development stages (small molecule, antibodies, antisense oligonucleotides, etc) and the challenges and opportunities associated with these. It will cover the stages involved in taking optimised lead compounds (or other drug types) through efficacy and toxicity evaluation, through to clinical trials. Learners will also acquire knowledge of the legal and regulatory aspects associated with the protection and marketing of a drug.

Learning outcomes

On successful completion of the module students will be able to:
1. Demonstrate an understanding of the applied concepts of preclinical evaluation of drug efficacy and toxicity.
2. Evaluate different types of drug that enter developmental stages.
3. Demonstrate an understanding of the applied concepts clinical evaluation of drug efficacy and toxicity.
4. Evaluate regulatory aspects of drug approval, marketing, and monitoring.

Skills Learning Outcomes

On successful completion of the module students will be able to:
1. Write in a clear, concise, focused and structured manner that is supported by relevant experimental evidence from the published literature

Syllabus

Details of the syllabus will be provided on the Minerva organisation (or equivalent) for the module

Teaching Methods

Delivery type Number Length hours Student hours
On-line Learning 30 1 30
Workshop 10 2 20
Private study hours 150
Total Contact hours 50
Total hours (100hr per 10 credits) 200

Opportunities for Formative Feedback

Short answer problem-solving exercises will be regularly delivered in workshop sessions with formative feedback.

Methods of Assessment

Coursework
Assessment type Notes % of formal assessment
Report Evidence-based report 50
Total percentage (Assessment Coursework) 50

Normally resits will be assessed by the same methodology as the first attempt, unless otherwise stated

Exams
Exam type Exam duration % of formal assessment
Online Time-Limited assessment 2.0 Hrs Mins 50
Total percentage (Assessment Exams) 50

Normally resits will be assessed by the same methodology as the first attempt, unless otherwise stated

Reading List

The reading list is available from the Library website

Last updated: 08/05/2024

Errors, omissions, failed links etc should be notified to the Catalogue Team