Introduction to Pharmacokinetics for the Non-specialist

The vast majority of failures at late stage clinical trials and post marketing are due to druginteractions.

Pharmacokinetics (PK) and pharmacodynamics (PD) play a key role in drug development, and a good understanding of the implications of PK/PD data is crucial when designing clinical trails or preparing a drug submission dossier.

Throughout the pharmaceutical and biotech industries, there is a general lack of understanding of these crucial areas of knowledge.

With PK data playing an ever more vital role in the development process, this lack of knowledge needs to be addressed, to increase real communication between departments. This course assumes no prior PK knowledge, and aims to give a broad understanding of this fascinating subject at a visual, rather than mathematical, level.

The main questions to be explored are:
• What is PK?
• What data is collected and how is it collected?
• Why is it important and how does it affect the
drug development process?

This is explored in two ways;  
The first part of the course focuses on an introduction to PK and an explanation of the classical methodologies of PK/PD studies.

The second part of the course moves on to examine the relevance of PK/PD studies on the various phases of drug development, and how this data can be used
more effectively in the go/no go decision and designing later stage clinical trials protocols.

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