FDA Critical Path Transporter Workshop
|Event Date/Time: Oct 02, 2008||End Date/Time: Oct 03, 2008|
At the conclusion of this meeting, participants should be able to:
â€¢ Describe the clinical significance of the transporters in drug exposure, toxicity and drugâ€“drug interactions.
â€¢ Discuss the characteristics of drugs that determine whether a transporter may be important.
â€¢ Evaluate the role of a transporters in clinical studies.
â€¢ Identify examples of clinically relevant effects on transport activity as evidenced by changes in pharmacokinetics, drug response and/or toxicity.
â€¢ Compare relevant model systems for studying transporters, including utility (how the model is used, what data is collected, how it is analyzed), requirements, advantages, disadvantages, current questions, issues and limitations of the model.
â€¢ Assess which model(s) would be most appropriate to use to answer specific questions.
â€¢ Identify gaps in knowledge regarding specific models or areas where new tools/models are really needed.