In Vitro ADME Profiling: Regulatory Perspective

In Vitro ADME is a critical part of a drug development regimen that helps predict the extent of a drug's availability to exhibit its therapeutic potential and how fast it will be eliminated from the body. In addition, patients often consume more than one drug at a time, which can impact the availability and elimination pathways through drug-drug interactions (DDIs). Regulatory authorities, including the FDA, EMA, PMDA and ICH, have issued guidelines on how to study potential DDIs in vitro and in vivo. This symposium will cover:

• Most recent DDI guidance documents, highlighting the differences from previous guidelines
• Impact of in vitro DDI studies on timing of the first-in-human studies and in vivo DDI studies
• Practical examples for implementing in vitro assays designed in compliance with DDI guidelines
• Case studies where an ADME issue was found late in development

Meet the Speakers

• Manu Kohli, Principal Scientific Advisor | Scientific Advisory Services, Charles River
• Joseph Zolnerciks, Director of Discovery In-Vivo Pharmacology, Charles River
• Michael Shockley, Principal Scientist II In Vitro, Charles River
• Krisztina Herédi Szabó, Principal Scientist, Transporter Services, Charles River