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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. 

BIOL21302 Pre-requisite is BIOL10822

• 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
 

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.

e-Learning Activities
• 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.
 

The summative written exam is an on-campus exam comprised of two sections, and is worth 75% of unit marks. Section A is based on short answer questions (answer 4 questions out of a choice of 6). Section B is a drug development case study.  Coursework involves a drug discovery game that mimics the drug discovery process by providing students with data for analysis, from which they decide on the next step, and is worth 25% of unit marks.  

• 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.

The year studying abroad is an integral part of the course and must be completed. Some costs, such as tuition fees, are substantially lower. Other costs can vary and are not included in the tuition fee. For example, living costs may be higher or lower than the UK, and there are travel-related costs to consider, such as paying for a passport, visa fees, health insurance, and (if needed) vaccinations.

All students should normally be able to complete their programme of study without incurring additional study costs over and above the tuition fee for that programme. Any unavoidable additional compulsory costs totalling more than 1% of the annual home undergraduate fee per annum, regardless of whether the programme in question is undergraduate or postgraduate taught, will be made clear to you at the point of application. Further information can be found in the University's (PDF document, 91KB).

Students participating in placements outside the UK may be able to apply for funding from the depending on eligibility. Priority will be given to students from low income households.