Pharmacokinetics in Drug Development - for the Non-Specialist
01 Jul 2013 - 02 Jul 2013 - London, UK
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.
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
What 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 development programme
- 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.
Numbers are restricted for maximum benefit to participants
Course will commence with registration at 8.30am, course proper at 9.00am and will finish at 5.00pm each day.
Day 1: Pharmacokinetic Principles
The principle processes involved in PK will be discussed and the jargon used in their description and quantification will be explained.
What is PK and why is it important
- Absorption, distribution, metabolism and elimination
- Therapeutic windows
- PK terminology
- Clearance, Volume of distribution
- Non compartmental Analysis
- Compartmental modelling
- PK/PD modelling
- Regulatory environment
- Data interpretation
Day 2: PK in Drug Development
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 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; co-medication 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
Several "learning in action" workshops during both days will provide participants with the opportunity to apply knowledge gained during the lectures.
Participants will need to bring along a scientific calculator