Spring Intro 2023

Mike Kelly

The Importance of Pharmacokinetics and Pharmacodynamics in Drug Development

Helen Walker, PhD Independent Clinical Pharmacology Consultant HW ClinPharm Ltd.

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Outline of presentation

 Definition of terms ● Pharmacokinetics, pharmacodynamics, clinical pharmacology, biopharmaceutics  Explore basic principles ● Pharmacokinetics ● Pharmacodynamics  Review different phases within clinical drug development ● Discuss the generation of relevant information around the pharmacokinetics and pharmacodynamics of a drug

AIM: To appreciate the importance of – Generating relevant PK and PD information

– Understanding the exposure-response (PK/PD) relationship – Understanding the factors that influence exposure, and therefore response throughout all phases of clinical drug development – To enable the selection and justification of the dosing regimen in the clinical setting

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