MSc Model-based Drug Development
Year of entry: 2023
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Course unit details:
Basic Pharmacokinetics and Pharmacodynamics
|Unit level||FHEQ level 7 – master's degree or fourth year of an integrated master's degree|
|Teaching period(s)||Full year|
|Available as a free choice unit?||No|
This introductory unit is designed to give the student an understanding of fundamental concepts in pharmacokinetics and pharmacodynamics, essentially how drugs get into the body, how they get around the body and how they get out of the body. Topics include the processes of absorption, distribution, metabolism and excretion (ADME), the concept of compartmental analysis, and basic statistical concepts.
Emphasis is given to explaining how chemical properties of drug interact with physiological aspects of the human body to affect the behaviour of different drugs and the variation between individual patients. Quantitative assessment of the processes (modelling and data analysis) is described with reference to drug discovery, drug development and therapeutic usage. The module also provides experience in solving numerical problems relating the time-course of drugs and their metabolites in the body.
This unit is a prerequisite for subsequent units which focus on physiologically-based models and advanced approaches to data analysis.
Theoretical knowledge will be disseminated an initial intensive week of lectures and tutored workshops. Students will then work on a series of structured assignments that emphasise the application of theory by solving problems. Some of the assignments will be computer based, to ensure students are comfortable with basic software for data analysis and presentation before encountering more specialised software in subsequent units.
The unit aims to:
· Provide information on the theory and methods for quantitative assessment of drug absorption, distribution, metabolism and excretion (ADME) in the human body.
· Introduce statistical concepts applied in the design of clinical trials and interpretation of clinical results.
· Provide an understanding of the role of pharmacometrics in the process of drug development, including scientific, regulatory and commercial perspectives.
Teaching and learning methods
· Workshops, entailing guided sequences of analyses with interactive discussion with tutor
· Directed reading
· Formative-assessed calculation-based coursework (pass/fail)
· Summative-assessed calculation-based coursework
Knowledge and understanding
· Describe the detailed mechanisms involved in drug absorption, distribution, metabolism and excretion (ADME).
· Explain the crucial roles of pharmacometric methods in developing and gaining regulatory approval for a medicine, and specifically the role of pharmacokinetics and biostatistics in guiding the design and conduct of clinical trials.
· Make informed predictions on the influence of any change in (ADME) mechanism on plasma drug concentration-time profile for a given substance,
· Critically analyse observations on plasma drug concentration-time profiles and characterise them quantitatively for the purpose of making inferences between different drugs, different patients, different conditions etc.
· Identify the reasons for differences in the time-courses of drug effect and plasma drug concentration.
· Apply basic biostatistical concepts and interpret statistical information arising from clinical trials.
· Perform calculations using fundamental pharmacokinetic equations
· Use computer software such as Excel or R to perform basic computational tasks including file input/output, calculations, and production of effective graphs
· Produce written reports on the pharmacokinetics of a given drug, making effective use of pharmacokinetic terminology.
|Written assignment (inc essay)||30%|
Feedback will be given within 15 working days for assignments and after the exam board has met for exams.
|Leon Aarons||Unit coordinator|