Theoretical and Practical Pharmacokinetics

*Please note that applicants to this short course should go via King's Apply (click red 'Apply' button on the right of this page) and select the following programme*:

Pharmaceutical Medicine Non-Award (Part-time)

Module code 7MMM0009

A comprehensive understanding of the principles of pharmacokinetics, pharmacokinetic/pharmacodynamic (PK/PD) relationships, and how to apply these principles to the design and evaluation of first-in-human single- and multiple dose studies is an essential component of the drug development process. This includes assessment of the pharmacokinetics of new molecular entities, with consideration of demographic factors, drug-disease interactions and drug-drug interactions. Examples of these interactions will be communicated during the course with modelling of PK/PD of specific drugs based on data provided.

By the end of this module participants will be able to:

• Understand the factors affecting the absorption, bio-availability, distribution, metabolism, clearance and excretion of drugs and be able to carry out the procedures and calculations required to determine the key PK parameters.
• Design studies to assess absolute and relative bio-availability and be able to calculate whether formulations are bio-equivalent.
• Interpret PK data obtained from a single dose escalation including dose proportionality, linearity and non-linearity.
• Understand how single dose data can be used to model the PK of repeated dosing, the importance of accumulation and fluctuation at steady state and the effects of changes in clearance and dose.
• Appraise the differences between the PK of small molecules and biologics.
• Appreciate the importance of robust handling of samples for assay and the bio-analytical techniques in common use.
• Understand how PK data in animals can be used to predict likely findings in humans.
• Understand the mechanisms involved in drug-drug interactions including effects on transporters and be able to use PK data to design such studies.
• Appreciate the effects on PK of food ingestion, demographics, pharmacogenomics and disease.
• Understand the design, analysis and interpretation of data obtained from a mass balance study.
• Understand the role of therapeutic drug monitoring in optimising drug dosage.
• Understand the importance and value of pharmacokinetic/pharmacodynamic modelling and population pharmacokinetics.

Minimum entry requirements are either a medical degree (such as an MBBS) or a 2:1 first degree in pharmacy, pharmacology, biology, biochemistry, chemistry or related subject.