Sessions
In-vitro methods to study transporter – drug interactions
• Identification of P-gp substrates - correlation studies
• In-vitro assays for BCRP
• Hepatic uptake transporters
• Data analysis and modelling of in-vitro drug transport studies
In-vitro methods to study metabolism of drugs
• Methods for measuring irreversible P450 inhibition
• P450 induction in a high throughput environment (FDA concern)
• Metabolite ID
In-vivo models and IVIVE
• KO animals for transporter and metabolism studies
• Humanized mice
• IVIVE: best practices or real-case scenario
Clinical Significance of transporters
• BSEP inhibition a mediator of toxicity
• Effect of OATP polymorphism on the pharmacokinetics of drugs
• Clinical significance of expression and polymorphism of transporters in tissues other than the liver Regulatory issues on ADME testing
• Regulatory hot topics – industrial point of view
• Regulatory hot topics in Japan
• Regulatory issues in Europe
Program is subject to change.
