Challenges & Solutions In Today’s In Vitro Transporter Research Landscape
Joanna Barbara, Ph.D., SEKISUI XenoTech Vice President of Scientific Operations
Originally Aired: 20 June 2018
- Ramifications of recent FDA in vitro DDI guidance changes to transporter study designs
- Challenges from diverse compounds in otherwise straightforward assays
- Solutions to problems associated with specific compound characteristics
- Case studies of problematic observations or data and the creative methods of troubleshooting applied
Recent changes to the FDA in vitro DDI guidance document have emphasized the need for more considered transporter study designs to better inform in vivo expectations for drugs in development. Additionally, challenges associated with some diverse compounds in what should have been straightforward in vitro transporter assays will be examined. Case studies will explore the problematic observations or data, creative methods of troubleshooting applied, and how we can learn from those experiences to better understand and address surprises in future transporter studies.