ADME 101: Model-Based Approaches to DDI Risk Prediction – Navigating the Transition from In Vitro Data to In Silico Modeling
Presenter: Pallavi Limaye, Ph.D., DABT, XenoTech Director of Scientific Consulting
This informative ADME 101 discusses In Vitro to In Vivo Extrapolation (IVIVE) and how a model-based approach following routine perpetrator potential studies (i.e. CYP inhibition, CYP induction, and transporter inhibition) assessing clinical potential may eliminate the need of conducting clinical studies. Listen in as Dr. Limaye outlines a step–wise approach for bringing robustness to the prediction, including:
- Regulatory guidance
- ADME & DDI study types for in vitro to in vivo prediction
- Models for DDI prediction
- Decision tree for whether modeling is needed
- Model equations by study type
About the presenter
Dr. Pallavi Limaye is a Director in the Scientific Consulting department. Pallavi completed her Ph.D. in Toxicology from The University of Louisiana and her postdoctoral research in the Department of Pathology at University of Pittsburgh Michalopoulos and subsequently at the Department of Pharmacology, Toxicology, and Therapeutics at University of Kansas Medical Center. Dr. Limaye originally joined XenoTech in 2011 as a Research Scientist and served as a study director for in vitro drug metabolism studies. In 2013, she joined Xenometrics LLC, as a Senior Scientist and served as a study director for regulated nonclinical IND- and NDA-enabling toxicology studies. From 2018 to 2020 Dr. Limaye worked at MRIGlobal as a Principal Scientist and oversaw nonclinical toxicology and animal health studies, as well as contributed to containment research with select chemical agents. Recently Dr. Limaye joined XenoTech’s consulting team and provides input on drug-drug interaction study needs for sponsors. Dr. Limaye has published several original research articles in various journals (Hepatology, Toxicological Sciences among others) and has also contributed many book chapters in the field of toxicology and liver pathobiology. Dr. Limaye is also actively involved in scientific societies and currently serves on the Program Committee of The American College of Toxicology and is the Vice President of the Central States regional chapter of The Society of Toxicology.
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