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Webinars

Webinar: Red Blood Cell Partitioning Studies to Improve Accuracy in Pharmacokinetics (PK) Calculations

Presenter: Steven McGreal, Ph.D, Study Director at SEKISUI XenoTech Abstract: Pharmacokinetic (PK) parameters of a new drug candidate are typically determined by measuring the drug’s...

Webinar: An Overview of Non CYP-Mediated Metabolism Pathways and In Vitro Evaluation Strategies

Presenter: Brian Ogilvie, Ph.D, Vice President of Scientific Consulting at SEKISUI XenoTech Abstract: Although cytochrome P450 (CYP)-mediated metabolism continues to be of major importance for...

2C or Not 2C: CYP2C Induction Studies for Successful Preclinical Risk Assessment

As a part of IND-enabling preclinical drug development studies companies are required to meet regulatory expectations to evaluate the induction potential of their compound for the cytochrome P450 CYP enzymes CYP1A2, 2B6, 2C8, 2C19 and 3A4.  While only CYP1A2, 2B6 and 3A4 must be assessed in the initial induction panel, any observed induction of CYP3A4 requires further investigation of induction potential for enzymes in the CYP2C family due to crosstalk between the PXR and CAR nuclear receptor pathways.  This webinar will focus on CYP2C induction and will emphasize when to include CYP2C induction in a study, how to design the study to generate meaningful data and meet the regulatory requirements, what endpoints to measure, and how to interpret results.

In Vitro Cholestatic DILI & Mitochondrial Toxicity Studies to Assess Hepatotoxicity

Drug-Induced Liver Injury (DILI) incidents account for more than 10% of all cases of acute liver failure, posing a major clinical and regulatory challenge. While the cause of DILI is multifactorial and difficult to predict, there are known mechanisms...

ADME 101: Drug Metabolism Studies – Metabolic Stability

Metabolic stability influences the oral bioavailability and plasma half-life of a compound. Metabolic stability assays measure intrinsic clearance and determine the extent to which a drug will be metabolized. This study can be conducted in a variety of test systems, which is why it may also be referred to as a hepatocyte stability study, microsomal stability study...

ADME 101: Model-Based Approaches to DDI Risk Prediction – Navigating the Transition from In Vitro Data to In Silico Modeling

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...

Hyaluronan (HA) Synthesis Inhibition Normalizes Hepatic Fibrogenic Features by Reducing Hepatic Stellate Cell Activation in Alcohol-Associated Liver Disease Models

Presenters: Michele Pritchard, Ph.D., Associate Professor, University of Kansas Medical Center and Maciej Czerwinski, Ph.D., Director of Consulting, SEKISUI XenoTech In 2018, Dr. Pritchard published...

Suicide by Binding: Putting Time-Dependent Inhibition of CYP Enzymes into Perspective

Presenter: Brian Ogilvie, Ph.D., SEKISUI XenoTech Vice President of Scientific Consulting with special guest for Q&A, Lois Haupt, SEKISUI XenoTech Principal Scientist in Program Oversight Many...

ADME 101: Biobank Fatty Liver Disease Tissues and Their Exploration in Microarrays

Presenter: Maciej Czerwinski, Ph.D., SEKISUI XenoTech Director of Consulting This ADME 101 discusses biobank tissue and its research applications. The Research Biobank was established to...

ADME 101: Enzyme Induction Studies

The clearance of a drug can be increased and its effectiveness or safety compromised if it is co-administered with a second drug that induces the enzyme responsible...

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