Pharmacokinetics in Drug Development - an integrated approach

Overview

The UK, like most developed countries, has an ageing population.In the 2001 population census, the average age was 39.0 years, an increase on 1971 when it was 34.1 years. In mid-2006 approximately one in five people in the UK were aged under 16 and one in six people were aged 65 or over.

With advancing age comes increased medicine use, furthermore elderly patients are likely to be taking several concomitant medications. This greater drug usage makes them more at risk of suffering from adverse events as a result of drug-drug interactions (DDIs). DDIs may be metabolic, transporter, physicochemical or dynamic in nature. In drug development, advances in in-vitro science and modelling software have helped to screen out compounds that are most at risk of DDIs before they enter into man. The need to investigate DDIs in the clinic though has not disappeared.

Several regulatory agencies have drug interaction guidances; in particular the FDA has recently released a draft guidance entitled "Drug Interaction Studies-Study Design, Data Analysis, and Implications for Dosing and Labeling" that takes account of current thinking in the field.

An understanding of the pharmacokinetic/pharmacodynamics of the compound, linked to the relevant regulatory guidances is required to deliver a safe and effective medicine that can be used by patients concomitantly with other remedies.

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?

• 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 PKPD modelling in drug development
• An appreciation of how regulatory guidances influence PK
• Increased confidence to discuss PK issues within their drug projects

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) who want to further their knowledge of the usefulness of PK in their projects.

Numbers are restricted for maximum benefit to participants

Course Programme

Course will commence with registration at 8.30am, course proper at 9.30am and will finish at 5.00pm each day.

Day 1: Pharmacokinetic Principles

What is PK and why is it important?

• Adsorption, distribution, metabolism and elimination
• Transporters
• Drug failures
• Therapeutic windows

PK terminology

• Clearance, Volume of distribution etc. What are they and what is there importance

PK techniques

• Non compartmental Analysis
• Compartmental modelling
• Population pharmacokinetics
• Regulatory environment
• Data interpretation

Day 2: PK in Drug Development

Pre-clinical/clinical interface

• What PK data are available, how does this influence the Clinical PK strategy?
• Biomarkers
• Implications for CTA - dose choice and dose escalation in first to man studies, adaptive dosing

Variability in PK

• Drug interactions; CYPs and transporters strategies and regulatory guidance; types of interaction competitive vs mechanism based; implications for study design (restrictions healthy volunteers vs patients etc)
• Genetic polymorphisms
• Renal and hepatic impairment

Biologics

• Pharmacokinetics/Pharmacodynamics
• Study Design
• Regulatory Environment

There will also be several "learning in action" workshops during both days where participants will have the opportunity to apply knowledge gained during the lectures. An open forum session will be held where delegates can bring along their own issues for discussion.

Participants will need to bring along a scientific calculator