LSC-30080 - Module Specification
School of Life Sciences
Faculty of Natural Sciences

Programme/Approved Electives for 2026/27

Available as a Free Standing Elective

Co-requisites

None

Prerequisites

None

Barred Combinations

None

Description for 2026/27

In this module you will further explore the drug development pipeline with a focus on the translation of drugs from pre-clinical studies and clinical trials to clinical practice. Including a greater awareness of diverse patient demographics and personalised medicine and how this should inform appropriate clinical trial design and participant recruitment. You will evaluate the design of clinical trials and the analysis/interpretation of the data generated in context to development of 'higher risk' drugs in application to selective toxicity and/or novel and emerging therapies (e.g. gene therapy, immunotherapy etc.). As part of this you will consider in more detail the associated ethical and regulatory frameworks applied to medicines management through organisations such as the National Institute for Health and Care Excellence (NICE) and the MHRA, as well as explore different international contexts and monitoring of potential toxicity/side effects in patient groups. Other areas of the module will consider the pharmacokinetics, mode of action, impact on human physiology and potential toxicity, poisoning, or adverse interactions of drugs derived from herbal products, including applications in traditional medicine. You will also develop further communication and analytical skills through the production of a case report to direct a clinical trial for the introduction and monitoring of a new drug regime to clinical practice and a short critique on a select example of drug candidates from natural products.

The module aims to further develop students' understanding of the design and conduct of pre-clinical and clinical studies in modern drug discovery, including data generated and its interpretation. Students will develop higher-level skills in the evaluation of clinical trial data and the regulatory frameworks that govern the translation of medicines into clinical practice and their monitoring, with consideration of differences in international approaches. Students will also evaluate how this is applied to 'higher risk' drugs, as well as novel and emerging therapies, considering mechanisms of cellular and tissue toxicity and monitoring in clinical practice. Toxicology will be further explored in context to traditional medicines, poisons and pesticides, considering herbal products/extracts and drug candidates developed from studies in these areas, with students producing a critique on a select agent.

Intended Learning Outcomes

evaluate the design and conduct of pre-clinical and clinical trails in the introduction of new therapeutic agents, including novel and emerging therapies, with consideration of study design, participant demographics, data required, its analysis and interpretation: 1
critically discuss how data from clinical trials is used to inform the translation of medicines into clinical practice and the associated regulatory frameworks for their introduction and monitoring: 1
discuss the processes by which drugs may exert toxicity in relevant model systems, the cellular defence mechanisms against this and the application of toxicology studies in drug discovery: 1
critically discuss the pharmacokinetic properties, mode of action and impact on human physiology of natural products, traditional medicines, poisons and their derived drug compounds, and the treatment of toxicity/poisoning: 2
abstract, synthesise, integrate and critically evaluate information from the scientific literature and other database, and communicate this effectively: 2

Study hours

Active learning hours:
12 x 1 hour case-based learning sessions
4 x 1 hour assessment workshops
8 x 1 hour workshops/tutorials supporting asynchronous content
6 x 4 hours engagement with asynchronous resources (initial consumption, note taking and supporting reading)
Independent study:
20 hours preparation for case-based learning sessions
34 hours preparation of critique
48 hours preparation of case report

School Rules

None

Description of Module Assessment