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Year of entry: 2023
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Course unit details:
Clinical Drug Development
|Unit level||Level 2|
|Teaching period(s)||Semester 2|
|Available as a free choice unit?||No|
Clinical Drug Development explains the science behind the discovery and development of new drugs, from initial ideas through to clinical use in man. You will learn that the effects of a drug depend not only on its actions (, 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.
|Unit title||Unit code||Requirement type||Description|
|Drugs: From Molecules to Man||BIOL10822||Pre-Requisite||Compulsory|
- To explain the processes by which new drugs are discovered and developed, from initial ideas through to full clinical use in man
- 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.
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
- 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.
• Several lectures are provided as on-line Softchalk lessons 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
- Analytical skills
- Throughout the course, students are drip-fed 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 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.
- Students will need to determine 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.
- Business awareness. Underpinning this unit is the need to understand the relationship between business aspects and the biosciences.
The summative written exam is an online 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 includes a drug discovery game (15%) that mimics the drug discovery process by drip feeding students data for analysis, from which they decide on the next step. Coursework also includes two short, online MCQ tests (5%).
- 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.
No single textbook covers the content of this unit. Links to e-textbooks with relevant sections are provided in the Course Content page.
|Scheduled activity hours|
|Assessment written exam||2|
|Independent study hours|
|Susan Cochran||Unit coordinator|
The assessment written exam is 2 hours plus 15mins upload time.