BSc Medical Biochemistry / Course details

Year of entry: 2024

Course unit details:
Clinical Drug Development

Course unit fact file
Unit code BIOL21302
Credit rating 10
Unit level Level 2
Teaching period(s) Semester 2
Available as a free choice unit? No

Overview

Clinical Drug Development explains the science behind the discovery and development of new drugs, from initial ideas through to clinical use in humans. You will learn that the effects of a drug depend not only on its actions (i.e., pharmacodynamics), but also on how an individual handles the drug (i.e., pharmacokinetics).  The course will outline how pharmacodynamic and pharmacokinetic studies are applied in the discovery and development of new drugs and the processes that follow to turn the new drug into a medicine that can be approved for use in patients. 

Pre/co-requisites

Unit title Unit code Requirement type Description
Drugs: From Molecules to Man BIOL10822 Pre-Requisite Compulsory
BIOL21302 Pre-requisite is BIOL10822

Aims

• To explain the processes by which new drugs are discovered and developed, from initial ideas through to full clinical use in humans
• To provide an understanding of what constitutes a drug and the mechanisms by which drugs produce effects on the body (i.e. pharmacodynamics)
• To provide an understanding of how drugs are affected by the body and how an individual’s handling of drugs (i.e. pharmacokinetics) is important in the development of new drugs 
• To delineate the processes followed to turn a new drug into a medicine and ensure that it is effective and safe for use in patients.
 

Learning outcomes

By the end of the Unit, and after private study, students should have knowledge and understanding of the:
• major approaches to drug discovery
• properties of drugs
• techniques used to identify drug targets and lead compounds
• methods for determining the pharmacological and toxicological properties of compounds
• role of pharmacokinetic principles in the drug discovery process
• preclinical and clinical evaluation of new drugs
 

Syllabus

• Overview: Medicines and discovery processes. 
• Initial stages: Target discovery; applications of molecular biology, in silico methods and assays; lead discovery; lead optimisation; biomarkers.
• Measurement of drug properties: assay techniques; agonists (full, partial, inverse and biased); competitive antagonists; in vivo models; pharmacokinetic profiles of compounds; pharmacogenetics; formulations; pre-clinical safety assessment.
• Later stages: Pharmaceutical development; clinical evaluation; concepts in clinical trial design.


e-Learning Activity
• Several lectures are provided as on-line Softchalk llessons with embedded links.
• An online software tool (eg Padlet) will be open to encourage dialogue between students.
• Coursework will involve completion of on-line tests.
• Links are provided to additional resources (further reading, videos, on-line activities) to support the lecture content.
• Online self-assessment modules on the course content are provided for formative feedback.
 

Employability skills

Analytical skills
Throughout the course, students are provided with data that they are required to analyse as a part of a drug discovery programme. The result determines the next step to be taken in the drug discovery process. Students will also be required to analyse data and experimental results for a live workshop.
Project management
Students spend approximately 9 weeks on a project that follows the steps involved in a drug development project, with information drip fed provided to them at regular intervals for analysis and assessment.
Oral communication
Live sessions give students an opportunity to discuss the content of the course with classmates and lecturers.
Problem solving
Students are required to analyse data at regular intervals during the course, from which they determine the next step to be taken in the drug discovery process. This will involve analysis of primary sources.
Research
Students will need to determine the appropriate experimental techniques to generate data for the drug discovery game. Additional reading material is provided to students with the lectures.
Written communication
Students will be required to answer short answer questions and work though a drug development case study in their written exam.
Other
Business awareness. Underpinning this unit is the need to understand the relationship between business aspects and the biosciences.

Assessment methods

Method Weight
Other 20%
Written exam 80%
Written exam 80% Coursework 20% The summative written exam is an on-campus exam based on short answer questions (answer 5 out of a choice of 8) plus a drug development case study (answer 1 out of 2) (80%). Coursework involves a drug discovery game (20%) that mimics the drug discovery process by providing students with data for analysis, from which they decide on the next step.

Feedback methods

  • An on-line discussion board (eg Padlet) is used to generate discussion among staff and students.
  • Online quizzes are available for formative feedback
  • Students receive feedback throughout the drug discovery game.

Recommended reading

No single textbook covers the content of this unit.  Links to e-textbooks with relevant sections are provided in the Course Content page.

Study hours

Scheduled activity hours
Assessment written exam 2
Lectures 22
Independent study hours
Independent study 76

Teaching staff

Staff member Role
Katherine Hinchliffe Unit coordinator

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