PharmaTraining, Window Conference Centre, Islington, London
28 & 29 June, 2010
Day 1: Pharmacokinetic Principles
What is PK and why is it important?
- Absorption, distribution, metabolism and elimination
- Drug failures
- Therapeutic windows
- Clearance, Volume of distribution etc. What are they and what is there importance
- Non compartmental Analysis
- Compartmental modelling
- Population pharmacokinetics
- Regulatory environment
- Data interpretation
Day 2: PK in Drug Development
- What PK data are available, how does this influence the Clinical PK strategy?
- 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
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.
- Study Design
- Regulatory Environment