Program Overview
The Theoretical and Practical Pharmacokinetics program at King's College London provides a comprehensive understanding of pharmacokinetic principles and their application in drug development. It covers topics such as PK/PD relationships, first-in-human studies, drug interactions, and bio-analytical techniques. The program is designed for individuals with a medical or science background and prepares graduates for careers in clinical research, drug development, and regulatory affairs.
Program Outline
Degree Overview:
Module code:
7MMM0009
Course title:
Theoretical and Practical Pharmacokinetics
Course type:
Continuing Professional Development (CPD)
Credit level:
7 The course provides a comprehensive understanding of pharmacokinetic principles, pharmacokinetic/pharmacodynamic (PK/PD) relationships, and their application in drug development. It focuses on the design and evaluation of first-in-human single- and multiple-dose studies. Participants will learn to assess the pharmacokinetics of new molecular entities considering demographic factors, drug-disease interactions, and drug-drug interactions. Examples of these interactions will be discussed with PK/PD modeling of specific drugs based on provided data.
Objectives:
- Understand factors affecting drug absorption, bio-availability, distribution, metabolism, clearance, and excretion.
- Perform procedures and calculations to determine key PK parameters.
- Design studies to assess absolute and relative bio-availability, and calculate bio-equivalence of formulations.
- Interpret PK data from single-dose escalation studies, including dose proportionality, linearity, and non-linearity.
- Differentiate the PK of small molecules and biologics.
- Appreciate robust sample handling for assay and common bio-analytical techniques.
- Understand the use of animal PK data to predict human findings.
- Understand mechanisms of drug-drug interactions, including effects on transporters, and design PK studies for these interactions.
- Appreciate the impact of food ingestion, demographics, pharmacogenomics, and disease on PK.
- Understand the design, analysis, and interpretation of data obtained from a mass balance study.
- Understand the role of therapeutic drug monitoring in optimizing drug dosage.
- Understand the importance and value of pharmacokinetic/pharmacodynamic modeling and population pharmacokinetics.
Target audience:
The course is designed for individuals with a medical degree (MBBS) or a 2:1 first degree in pharmacy, pharmacology, biology, biochemistry, chemistry, or related subject.
Outline:
Content:
- Principles of pharmacokinetics
- Pharmacokinetic/pharmacodynamic (PK/PD) relationships
- Design and evaluation of first-in-human single- and multiple-dose studies
- Assessment of the pharmacokinetics of new molecular entities
- Drug-disease interactions
- Drug-drug interactions
- PK of small molecules and biologics
- Bio-analytical techniques
- Animal PK data in human predictions
- Food and PK
- Demographics and PK
- Pharmacogenomics and PK
- Disease and PK
- Mass balance studies
- Therapeutic drug monitoring
- Pharmacokinetic/pharmacodynamic modeling
- Population pharmacokinetics
Structure:
The course will consist of lectures, workshops, and case studies.
Course schedule:
The course schedule will be provided to participants upon enrollment.
Individual modules:
The course consists of one module: Theoretical and Practical Pharmacokinetics (module code: 7MMM0009).
Module description:
The module provides a comprehensive understanding of the principles of pharmacokinetics, PK/PD relationships, and their application in the drug development process. It focuses on the design and evaluation of first-in-human single- and multiple-dose studies, with a focus on demographics, drug-disease interactions, and drug-drug interactions. The module will also cover the PK of small molecules and biologics, bio-analytical techniques, animal PK data in human predictions, food and PK, demographics and PK, pharmacogenomics and PK, disease and PK, mass balance studies, therapeutic drug monitoring, and pharmacokinetic/pharmacodynamic modeling and population pharmacokinetics.
Assessment:
Assessment methods:
- Written assignments
- Oral presentations
- Case studies
Assessment criteria:
- Accuracy
- Completeness
- Clarity
- Critical thinking
- Problem-solving
Teaching:
Teaching methods:
- Lectures
- Workshops
- Case studies
- Group discussions
Faculty:
The course will be taught by experienced academics and industry professionals with expertise in pharmacokinetics and drug development.
Unique approaches:
The course will use a variety of teaching methods to ensure that all students have the opportunity to learn and engage in the material. The coursework will include lectures, workshops, case studies, and group discussions.
Careers:
Potential career paths:
- Clinical research scientist
- Pharmacist
- Drug development scientist
- Regulatory affairs specialist
- Medical writer
Career opportunities:
The course will prepare graduates for a variety of careers in the pharmaceutical industry, government, and academia.
Career outcomes:
Graduates of the course have gone on to work in a variety of positions within the pharmaceutical industry, including clinical research, drug development, regulatory affairs, and medical writing.
- Participants are required to bring a laptop with them to the course.
- The course fee includes all materials and refreshments.
- The course is offered by the Institute of Pharmaceutical Science at King's College London.