Spring Intro 2023

Mike Kelly

PK Sampling In Phase I

 Many samples taken from each individual  PK sampling schedule designed to ensure good definition of the Cmax and Tmax, and the terminal phase of the curve, and therefore t1/2.  Collect a lot of data on a relatively small number of individuals  Generate average and a measure of variablity for each parameter in the different studies

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Other Phase I studies: Clinical Pharmacology Studies to Support Regulatory Package

 Pharmacokinetics is a primary objectives in all these studies  Data generated from these studies informs prescribers and patients of contraindications and populations that are at increased risk of safety issues or lack of efficacy

 Food Interaction  Effect of Age & Gender  Drug-drug Interactions  Special Populations ● Renally Impaired ● Hepatically Impaired ● Elderly, paediatrics ● Effect of ethnicity  Human ADME  Absolute bioavailability

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