Pharmacokinetics in special populations

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Overview

A perennial question within drug development is whether the same drug dose can be given across all sub-groups within a disease population. Is it enough to target the typical patient" A problem arises with this approach as the typical patient is difficult to define. In cardiovascular disease the patient population is skewed towards individuals over 45 years of age. Conversely asthma is common across all ages. At both ends of the age spectrum physiological processes such as hepatic and renal function differ to those of a healthy adult. An understanding of how these physiological changes affect the pharmacokinetics of a drug will aid the selection of the right dose for the right patients at the right time.

The aim of this course is -

To provide participants with the knowledge and understanding that will allow them to design and interpret the PK from studies in special populations.

What will participants gain -

Following the course attendees will have an understanding of how key pharmacokinetic parameters are affected by the physiological changes brought about during ageing and disease. Additionally they will have an overview of the design elements required in clinical studies of new medicines/formulations to allow the estimation of PK parameters in special populations

How will participants learn

Participants will learn through a mixture of formal lectures and learning in action workshops. The learning in action sessions are designed to complement and reinforce the formal teaching through individual and group exercises.

Who Should Attend?

Participants should have a basic knowledge of pharmacokinetic concepts. The course would benefit individuals that have to design PK studies and either interpret or review the subsequent data generated. For example, clinical scientists, project pharmacokineticists, project directors, statisticians and clinicians.

Course Programme

9.00am   Introduction

9.15     Influence of renal and hepatic impairment on Clearance and Volume

10.00   Workshop: case studies

10.30   Tea/coffee

11.00   PK Design considerations in hepatic/renal impairment studies

11.45   Workshop: case studies

12.30   Lunch

1.30    Clearance and Volume in children

2.30    Workshop: case studies

3.00    Tea/coffee

3.15    PK Design considerations in paediatric studies

4.00    Workshop: case studies

4.45    Concluding remarks

5.00pm   Close

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