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Integrated Approach to Pharmacokinetics in Drug Development

 
  February 27, 2010  
     
 
PharmaTraining, Window Conference Centre, Islington, London
28 & 29 June, 2010


Day 1: Pharmacokinetic Principles

Topics

What is PK and why is it important?

  • Absorption, 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
  • Paediatrics

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.
 
 
Organized by: PharmaTraining
Invited Speakers:

Dr Graham Blakey, GBPK Consulting Ltd

 
Deadline for Abstracts: N/A
 
Registration: Register Online
E-mail: judy@pharma-training-courses.com
 
   
 
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