Driving Knowledge From Laboratory to Label
August 4th & 5th, 2014
8:00am - 5:00pm
The interest in the field of transporters and their impact on drug absorption and disposition has been re-invigorated due to recent FDA and EMA guidance on approaches to assess transporter mediated DDI liabilities for NME. Therefore, this course is designed to serve a variety of scientific communities.
-Senior level managers and industrial, biopharmaceutics and contract research organization (CRO) scientists desiring to understand the overall role of transporters in drug absorption and disposition, subsequently to design compounds with transporter interaction for the optimization of PK/safety profiles.
-Regulatory scientists who needs to understand recent FDA and EMA regulations on drug transporters DDI.
-Scientists who develop and conduct in vitro transporter studies and/or in vivo pharmacokinetic studies.
-Registrants should possess a basic knowledge of drug discovery and development.
By the end of workshop, students will understand the role of transporters in drug disposition, physicochemical properties needed for NMEs to avoid or be substrates for various transporters. Also how to interpret data generated in in vitro/in vivo settings. It will also provide a better understanding of the recent FDA and EMA regulations and how to put them in context from drug development setting. This course will also provide an overview on approaches to characterize the potential for transporters mediated drug-drug interaction using both static and dynamic mechanistic/ whole-body PBPK modeling.
Tuesday, August 5, 2014 at 8:00am to 5:00pm
Pharmacy- Paramaz Avedisian ’54 Hall
7 Greenhouse Road, Kingston, R.I.
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