ToXchange The Basics of In Vitro Xenobiotic Metabolism and Drug-Drug Interaction Investigations
SOT Virtual CE Course: AM07
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Chair(s): Andrew Parkinson, XPD Consulting; and Brian Ogilvie, Sekisui XenoTech LLC.
Primary Endorser:
In Vitro and Alternative Methods Specialty Section
Other Endorser(s):
Drug Discovery Toxicology Specialty Section; Exposure Specialty Section
In the current landscape of drug development and investigation of environmental chemicals, many personnel with toxicology backgrounds find themselves overseeing not only preclinical safety assessments but also in vitro xenobiotic metabolism and interaction studies. Therefore, the goal of this course is to provide attendees with practical perspectives from experts in the field on the approaches and techniques that are available to address the important aspects of xenobiotic metabolism. The first presentation will focus on the experimental design and interpretation of data obtained from studies of in vitro inhibition of cytochrome P450 (CYP) and other xenobiotic-metabolizing enzymes. In contrast, the second presentation will focus on the experimental design and interpretation of data obtained from studies of in vitro induction of CYP and other xenobiotic-metabolizing enzymes. The third talk will broaden considerations of xenobiotic metabolism, including assessment of the toxicological burden of reactive metabolites, and the experimental design and interpretation of data obtained from studies of in vitro reaction phenotyping techniques in human liver microsomes and other test systems derived from humans or toxicologically relevant species. The fourth presentation will discuss in vitro approaches for determining the potential for xenobiotics to be substrates or inhibitors of major transporters that are of regulatory interest and interpretation of the data obtained from these studies. The final presentation will discuss the practical implications of the in vitro approaches discussed and the current regulatory thinking on their applicability to all xenobiotics to which humans are exposed. The overarching objective of this course is to provide attendees with a solid foundation in commonly used methods to enable the design, execution, and interpretation of rigorous and reproducible in vitro xenobiotic metabolism and interaction studies that will withstand regulatory scrutiny and avoid common pitfalls. This course will benefit those whose toxicological interests are expanding to include in vitro xenobiotic metabolism, as well as professionals responsible for appraising or evaluating in vitro xenobiotic metabolism, interaction studies, and other ADME data for internal decision-making, risk assessment, or submission to various regulatory agencies.
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The Basics of In Vitro Xenobiotic Metabolism and Drug-Drug Interaction Investigations
Introductory Remarks on Xenobiotic Metabolism and Course Overview. Andrew Parkinson, XPD Consulting, Shawnee, KS.
The Basics of In Vitro CYP Inhibition Studies for Regulatory Submission and Risk Assessment. Brian Ogilvie, Sekisui XenoTech LLC, Kansas City, KS.
The Basics of In Vitro CYP Induction Studies for Regulatory Submission. Diane Ramsden, Alnylam Pharmaceuticals Inc., Cambridge, MA
In Vitro Reaction Phenotyping and the Toxicological Burden of Reactive Metabolites. Jed Lampe, University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, Aurora, CO.
Xenobiotic Transporter Studies for Regulatory Submission. Caroline Lee, Arena Pharmaceuticals Inc., San Francisco, CA.
The Science of Drug Interactions Is Applicable to All Xenobiotics. Andrew Parkinson, XPD Consulting, Shawnee, KS.
Certificates
Course certificates are available to anyone who has registered for the course through SOT. If you would like to receive a certificate of completion, please contact us.
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