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ADME 101™

Scientific Resources ADME 101™

ADME 101™ is a new mini-webinar series of presentations by our scientists which highlight relevant aspects of ADME properties of drugs, assays we perform, topical regulatory considerations, overviews of related components of an IND, and more.

This series of educational short videos is constantly growing to represent a comprehensive resource for researchers and industry professionals to navigate ADME, DMPK, and DDI within the complex landscape of drug development. As we continue to update and add to our repository of resources, we welcome questions and requests for topics our experts may address in future presentations. Please use our online forms to request a topic or get in touch with our team.

 

Webinars

RI-ADE ADME 101: Non-clinical pharmacokinetics studies using radio-labeled compounds

Presenter: Satoshi Ito, Drug Development Solutions Center ADME Group Manager, Sekisui Medical Radio-labeled compounds can be used to provide important information during the drug development process....
Hepatocyte Tips
Blog

FAQ: Using Plateable Hepatocytes in In Vitro Assays

Plateable hepatocytes are often used for induction studies and to research metabolism, biochemistry, virology, host/pathogen interactions, and cell biology. Here,...

Dr. Andrew G. Taylor
Webinars

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...
Dr. Joanna Barbara
Blog

Ask Me Anything About In Vitro ADME, Drug-Drug Interaction Approaches and Strategies

Last month, Dr. Joanna Barbara joined AAPS for an online Q&A in their ongoing “Ask the Experts” series. As regulatory...

FDA approved button
Blog

Are in vitro drug metabolism and drug-drug interaction studies critical for an IND?

A Guide to What, Why & When to Conduct ADME Studies When drug developers are preparing their IND, drug metabolism...

4 Ways De-Risking Maximizes Compound Value
Blog

4 Ways De-Risking Maximizes Compound Value

Since most new drugs fail because of ADME/Tox, you can add considerable value to your compound by conducting early in...

Test Systems
Blog

Which Hepatocytes Should I Use for What Studies?

Primary hepatocytes are considered the gold standard for ADME/DMPK studies because they are the most representative in vitro test system. However, not all hepatocyte formats…

Dr. Kusum Parikh, Senior Scientist, Program Oversight
Webinars

ADME 101: Microsomal Protein Binding of Drugs

Presenter: Kusum Parikh, MBBS, PhD, XenoTech Senior Scientist in Program Oversight Abstract: Regulatory guidance states that drug developers should correct for nonspecific binding in microsomes...
Miki Fujishima, Drug Development Solutions Center
Webinars

Reactive Metabolite Detection Studies: Cysteine Trapping

Presenter: Miki Fujishima, Manager in Business Development at the Drug Development Solutions Center in Tokai, Japan. Abstract: Drug-induced liver injury (DILI) is caused by various...
SAFETY FIRST Ebook: Assessing drugs early can preclude regulatory and health issues
Publications

SAFETY FIRST: Assessing drugs early can preclude regulatory and health issues

Authors: Madison Esely-Kohlman, Dr. Maciej Czerwinski, Dr. Pallavi Limaye, Dr. Brian Ogilvie A Guide to When & Why to Evaluate ADME/PK & Drug-Drug Interactions With...
Webinars

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...
Webinars

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...
Webinars

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

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

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...
Webinars

ADME 101: Which Hepatocyte Test System Should I Use?

Presented by Chris Bohl, Ph.D., Global Technical Support Manager This ADME 101 video provides an overview of different types of hepatocytes, their unique benefits, and...
Webinars

ADME 101: Efflux and Uptake Drug Transporters

Presented by Andrew Taylor, Ph.D., Services Technical Support Manager Drug transport can be thought of as the AD&E in ADME, as transporters are responsible for absorption, distribution,...
Webinars

ADME 101: Reaction Phenotyping Studies in Drug Metabolism

Presenter: Andrew Taylor, Ph.D., Services Technical Support Manager It is important to identify the enzymes that significantly contribute to the metabolism of a drug candidate...
Webinars

ADME 101: Lysosomal Trapping

Presenter:  Andrew Taylor, Ph.D., Services Technical Support Manager This ADME 101 video discusses how compounds can become trapped by lysosomes, which can lead to high...
Webinars

ADME 101: Guide to Subcellular Fractions and When to Use Which Test System

Presenter:  Chris Bohl, Ph.D., Global Technical Support Manager This ADME 101 video provides an overview of different types of subcellular fractions, such as microsomes, S9,...
Blog

What is DMPK and how does it fit into drug development?

Drug metabolism and pharmacokinetics (DMPK) is a core discipline in drug development that considers the biotransformation of a drug compound...

Medical pill vector art
Blog

ADME and Drug-Drug Interactions for the Toxicologist

Highlights from the recent webinar presented by our newest expert consultant, Dr. Pallavi Limaye In her recent webinar (now available for...

Webinars

In Vitro ADME & Drug-Drug Interaction Considerations for Toxicologists

In vitro ADME and drug-drug interaction (DDI) investigations are early activities in the drug development process that are critical for framing downstream decision making. This ADME 101 webinar will provide insights at a high-level related to regulatory drivers, investigatory objectives, and practical concerns for such studies that are relevant to interested general toxicologists. Participants will gain insight as to the critical need and utility for in vitro ADME and DDI investigations as related to drug development. Regulatory expectations will be reviewed as will points of particular interest for enabling successful achievement of investigatory goals...
Compound entering cell
Blog

What is ADME and how does it fit into drug development?

The main aim of drug development is to get a compound that has a therapeutic effect into the form of...

Webinars

ADME 101: Considerations & Calculations When Sending In Vitro Test Articles

Presenter: Patrick McAnulty, XenoTech Scientist II, Program Design This ADME 101 webinar discusses the #1 most frequently asked question that our Protocol Design team receives:...
Pill releasing compound
Blog

In Vitro Evaluation of Drug-Drug Interaction (DDI) Potential

In its most recent in vitro drug interaction guidance update, the US Food and Drug Administration (FDA) emphasized harmony with the...

Design and planning
Blog

Four ways to optimize preclinical in vitro data to mitigate risk of late-stage clinical failure

1. Collect high-quality data to make informed, confident go/no go decisions for moving your drug candidate forward If you need...

Blog

How can in vitro and in vivo studies help me understand my drug’s clearance?

Systemic clearance, denoting how much drug is cleared from a volume of blood per unit of time, is of critical...

Webinars

ADME 101 FAQ: Tips & Tricks for Working with Plateable Hepatocytes

Presenter: Halee McElhaney, XenoTech Team Lead, Quality Control In the latest installment of ADME 101, one of our hepatocyte experts answers frequently asked questions about plateable...
Webinars

ADME 101: Metabolite ID & Characterization Studies FAQ

Presenter: Mark Horrigan, XenoTech Principal Scientist, Program Oversight In this short, information-packed ADME 101 video, one of our study directors discusses the main frequently asked questions...
Blog

Timing of In Vitro Studies: Early, Thorough ADME for Your Compound’s Success

Beyond the need for evidence that a drug works, Food and Drug Administration (FDA) and other regulatory bodies around the...

FDA approved button
Blog

How Can I Make Sure My Data Meets Regulatory Expectations?

Regulatory authorities publish updated guidance documents that share their expectations for endpoints and test systems with drug developers, but sometimes it is difficult to...

FDA Approval stamp
Blog

What In Vitro Metabolism and DDI Studies Do I Actually Need?

Though there is no ‘roadmap’ spelling out required studies to achieve regulatory approval for clinical entry, a drug candidate’s metabolism...

Researcher pointing at Molecules
Blog

I Have My Data… Now What?

As a drug moves through the development pipeline, it undergoes a rigorous battery of safety assessments to prove it will...

Webinars

ADME 101: DMPK and ADME in Drug Development

Presenter: Joanna Barbara, Ph.D., Vice President of Scientific Operations at XenoTech We are pleased to present XenoTech’s first ADME 101 series webinar, Acronyms Abound: DMPK and...
FDA approved button
Blog

The FDA has requested follow-up data… how do I fill in the gaps?

Because each new drug is unique in characteristics, such as chemical structure, mechanism of action, and physicochemical properties, there can...

Test system guide
Blog

How to Choose the Right Test Systems for Your DMPK Studies

Test systems for DMPK in vitro studies are part of the very foundation of our company. Our labs were borne of...