MSc Model-based Drug Development - Pharmacokinetic and Pharmacodynamic Modelling

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 pharmacokinetic-pharmacodynamic 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 essential for subsequent units which focus on physiologically-based models and advanced approaches to data analysis in pharmacokinetics and pharmacodynamics. Theoretical knowledge will be disseminated in lectures and tutored workshops. Students will then work on a series of structured assignments that emphasise the application of theory by solving problems.

The unit aims to:

• provide an understanding of the physiological and drug-specific parameters that influence the pharmacokinetics of a drug
• provide information on the theory and methods for quantitative assessment of drug absorption, distribution, metabolism and excretion (ADME) in the human body
• teach methods for assessment of the pharmacokinetics of a drug following single and multiple dose administration
• teach method for application of knowledge to the rational design of dosage regimens
• introduce the link between pharmacokinetics and pharmacodynamics in clinical pharmacology.
   

• Lectures.
• Workshops, entailing guided sequences of analyses with interactive discussion with tutor.
• Directed reading.
• Formative-assessment provide feedback.
• Summative-assessed calculation-based coursework and written report.
   

• Describe the detailed mechanisms involved in drug absorption, distribution, metabolism and excretion (ADME).
• Explain the crucial roles of pharmacokinetics and pharmacodynamics in developing new drugs and in dosage regimen design.
   

• 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.
• Explain observed link between pharmacokinetics and pharmacodynamics. 
   

• Perform calculations using fundamental pharmacokinetic equations
• Design dosage regimen given a set of pharmacokinetic parameters, especially in during disease condition e.g., renal impairment.
• Produce written reports on the pharmacokinetics of a given drug, making effective use of pharmacokinetic terminology.

Feedback will be given within 15 working days for assignments and after the exam board has met for exams.

Rowland and Tozer's Clinical Pharmacokinetics and Pharmacodynamics: Concepts and Applications, Hartmut Derendorf, Stephan Schmidt, Malcolm Rowland, 5th edition, Wolters Kluwer, Philadelphia, 2020.

Assessment written exam - 2 hours

Lectures - 20 hours

Workshops - 22 hours

Webinars (part-time students) - 12 hours

Independent study hours - 109 hours