Corporate Banner
Satellite Banner
Biologics & Bioprocessing
Scientific Community
 
Become a Member | Sign in
Home>Events>This Event
  Events - July 2013


Pharmacokinetics in Drug Development - for the Non-Specialist

01 Jul 2013 - 02 Jul 2013 - London, UK



Bookmark and Share


In drug development clinical pharmacology is tasked to ensure that patients receive the right dose at the right time. This ensures that the new medicine is safe and effective throughout the patient population. To achieve this goal, it is necessary to recognise the factors that can alter drug response. Knowledge of pharmacokinetics (PK) and pharmacokinetic/pharmacodynamic (PK/PD) relationships is at the heart of this endeavour. For many drugs, clinical pharmacology information accounts for almost 50% of the final drug label, further emphasising the importance of PK understanding in drug development.

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-

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

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, Medical writers) 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 9.00am and will finish at 5.00pm each day.

Day 1: Pharmacokinetic Principles

The principle processes involved in PK will be discussed and the jargon used in their description and quantification will be explained.

What is PK and why is it important

  • Absorption, distribution, metabolism and elimination
  • Therapeutic windows
  • PK terminology
  • Clearance, Volume of distribution

PK techniques

  • Non compartmental Analysis
  • Compartmental modelling
  • PK/PD modelling
  • Regulatory environment
  • Data interpretation
  • Reporting

Day 2: PK in Drug Development

The application of PK in clinical development will be addressed by looking at questions that commonly arise within drug projects. Examples include: "What are the implications of pre-clinical PK findings on the design of early phase development studies"; "How is the clinical relevance of a drug drug interaction assessed" and "What are the sources of variability in pharmacokinetic response".

Early phase development

  • Dose choice in first in human studies
  • Drug interactions; CYPs and transporters, strategies and regulatory guidance; types of interaction competitive vs mechanism based; co-medication strategy for patient studies
  • Radiolabel studies to assess routes of elimination
  • Assessing bioequivalence (oral and inhaled routes)

Variability in PK

  • Genetic polymorphisms
  • Influence of age
  • Food effects

Several "learning in action" workshops during both days will provide participants with the opportunity to apply knowledge gained during the lectures.

Participants will need to bring along a scientific calculator



Further information
Scientific News
Less May Be More in Slowing Cholera Epidemics
Mathematical model shows more cases may be prevented and more lives saved when using one dose of cholera vaccine instead of recommended two doses.
NIH Launches Human RSV Study
Study aims to understand infection in healthy adults to aid development of RSV medicines, vaccines.
Flu Remedies Help Combat E. coli Bacteria
Physiologists from the University of Zurich have now discovered why the intestinal bacterium Escherichia coli (E. coli) multiplies heavily and has an inflammatory effect.
'Fountain of Youth' Protein Points to Possible Human Health Benefit
Patients with higher blood levels of growth factor have lower risk of cardiovascular problems.
Lemon Juice and Human Norovirus
Citric acid may prevent the highly contagious norovirus from infecting humans, scientists discovered from the German Cancer Research Center.
Study Backs Flu Vaccinations for Elderly
Brown University researchers found vaccines well matched to the year’s flu strain significantly reduce deaths and hospitalizations compared to when the match is poor, suggesting that vaccination indeed makes a difference.
Inciting an Immune Attack on Cancer Cells
A new minimally invasive vaccine that combines cancer cells and immune-enhancing factors could be used clinically to launch a destructive attack on tumors.
Protein Found to Play a Key Role in Blocking Pathogen Survival
Calprotectin fends off microbial invaders by limiting access to iron, an important nutrient.
Major Advance Toward More Effective, Long-Lasting Flu Vaccine
Collaboration shows vaccine candidate can produce powerful ‘broadly neutralizing antibodies’ in animal models.
Immune System: Help for Killer Cells
A study from the University of Bonn may show the way to more effective vaccines.
Scroll Up
Scroll Down
SELECTBIO

Skyscraper Banner
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!