Design Intricacies and Decision Making Strategy for Drug Drug Interaction Studies
Presenter: Andrew G. Taylor, Ph.D., Manager of Technical Support for Services at XenoTech
Conducting in vitro ADME drug-drug interaction (DDI) studies early on in the drug development process is more than simply a box checking exercise to satisfy regulatory requirements. The information provided by these studies provides a deeper understanding of the molecule to the drug developer helping to inform go or no-go decisions early on.
Additionally, these studies are important to help prepare for clinical studies by providing data for FIH dose prediction and potential DDI risks. While in vitro ADME DDI studies might appear deceptively simple, maximizing the information gained from them can be complex, and benefits greatly form expert design and interpretation.
In this presentation we will discuss the main types of in vitro ADME studies that are required by the regulatory agencies, timing on when to conduct these studies, and highlight the importance of proper study design and data analysis.
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About the Presenter:
Dr. Andrew G. Taylor received his Ph.D. from University of California San Diego. He joined XenoTech as a research scientist in 2017, serving as a Study Director in nonclinical drug interaction contract studies compliance with Good Laboratory in Practices (GLP), OECD Principles of GLP, &/or Japan MOHW GLP Standards and specializing in drug transport and drug metabolism studies. He became the Technical Support Manager for services in 2020 and provides valuable guidance to ensure research needs are being met.