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 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.
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.
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.
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.
