In drug development clinical pharmacology is tasked to ensure that patients receive the right dose at the right time. This ensures that the new medicine is safe and effective throughout the patient population. To achieve this goal, it is necessary to recognise the factors that can alter drug response. Knowledge of pharmacokinetics (PK) and pharmacokinetic/pharmacodynamic (PK/PD) relationships is at the heart of this endeavour. For many drugs, clinical pharmacology information accounts for almost 50% of the final drug label, further emphasising the importance of PK understanding in drug development.
Course will commence with registration from 8.30am, course proper at 9.00am and will finish at 5.00pm each day.
The application of PK in clinical development will be addressed by looking at questions that commonly arise within drug projects. Examples include: ‘What are the implications of pre-clinical PK findings on the design of early phase development studies?’; ‘How is the clinical relevance of a drug interaction assessed?’ and ‘What are the sources of variability in pharmacokinetic response?’.
Participants will need to bring along a scientific calculator
Course Objectives:
To provide participants with an overview of the principles of PK and PK/PD modelling and how, together with regulatory guidances, they can be used to effectively deliver drug development programmesWhat will participants gain?
- Increased confidence to discuss PK issues within their drug projects
- Understanding of the common PK terms and their importance
- Understanding of how PK data influences the clinical developmentProgramme
- An understanding of the factors that contribute to variability in PK
- The role of PK/PD modelling in drug development
- An appreciation of how regulatory guidances influence PK
Who Should Attend?
The course is intended for all professionals in the drug development arena especially those that work in or with clinical project teams (eg Regulatory Affairs specialists; Medical personnel; Project Managers/Leaders; Clinical Research Associates; Medical Writers) who want to further their knowledge of the usefulness of PK in their projects.Course objectives:
To provide participants with an overview of the principles of Pharmacokinetics and Pharmacokinetic/Pharmacodynamic modelling and how together with regulatory guidances they can be used to effectively deliver drug development programmes.Course will commence with registration from 8.30am, course proper at 9.00am and will finish at 5.00pm each day.
Course Programme
Day 1: Pharmacokinetic Principles- What is PK and why is it important?
- Absorption, distribution, metabolism and elimination
- Therapeutic windows
- PK terminology
- Clearance, Volume of distributionPK techniques
- Non compartmental Analysis
- Compartmental modelling
- PK/PD modelling
- Physiologically based PK modelling
- Regulatory environment
- Data interpretation
- Reporting
The application of PK in clinical development will be addressed by looking at questions that commonly arise within drug projects. Examples include: ‘What are the implications of pre-clinical PK findings on the design of early phase development studies?’; ‘How is the clinical relevance of a drug interaction assessed?’ and ‘What are the sources of variability in pharmacokinetic response?’.
- Early phase development
- Dose choice in first in human studies
- Drug interactions; CYPs and transporters, strategies and regulatory guidance; types of interaction competitive vs mechanism based; comedication strategy for patient studies
- Radiolabel studies to assess routes of elimination
- Assessing bioequivalence (oral and inhaled routes)Variability in PK
- Genetic polymorphisms
- Influence of age
- Food effects
Participants will need to bring along a scientific calculator
