Author: wpengine

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

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

The FDA has released a new draft guidance for industry titled “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics.”...

What are drug transporters? Drug transporters are membrane-bound proteins that assist in the movement of drugs into or out of...

Over the years, we have received a lot of questions about cytochrome P450 (CYP) 2C induction studies. In February of...

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…

Many compounds bind to or diffuse into red blood cells (RBCs), which can significantly impact clearance and cause inaccuracies in PK calculations...

A recap of some of the important and promising research that was presented at the Transporters in Drug Discovery and Development symposium...

You may have heard about the patented CryostaX® format of hepatocyte pellets, but do you know why XenoTech and countless other researchers have made the…

Agility and focused growth allow drug developers to outsource expertise and benefit the industry at-large by fostering innovation. Panelists at the 2021 Annual DMDG Meeting…

Repurposing (repositioning, re-profiling, or re-tasking) a drug potentially saves years of costly testing from going to waste and potentially providing a higher chance of success.…

In preclinical development, a drug will be evaluated for potential to cause a drug-drug interaction (DDI) using in vitro experiments and then calculations that...

The main goal of preclinical toxicokinetic (TK) studies is to establish a correlation between a candidate compound’s concentration or dose...

“Given the rapid spread of COVID-19 and its relatively high mortality, filling the gap for coronavirus-specific drugs is urgent. […]...

As we begin this summer, many of us are grieving opportunities lost for parties and pool days with friends and...

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

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

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

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

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

In vivo determination of drug localization in tissue can be uniquely informative to drug developers investigating distribution within the context of...

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

In vivo mass balance studies are an important element of nonclinical drug development, to inform first in-human (FIH) studies and to...

A quantitative whole body autoradiography (QWBA) study provides data required for Human Radiolabeled ADME Studies1. Quantitative whole body autoradiography (QWBA) is an in...

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

Generally, a drug’s effects on enzyme and transporter activity are examined independently in a drug development program, but what if...

When putting together a data package for regulatory approval by the FDA, EMA, or PMDA, there is a lot to...

This year at XenoTech we celebrate our 25th birthday, and our partner in Japan turns 64! Looking back over our history,...

Dr. Ogilvie’s presentation discusses critical literature and case studies which have been published following the FDA’s 2017 guidance revision, and covered...

Getting reliable, reproducible results from studies using hepatocytes as a model system for drug metabolism is in part dependent on how well...

Why do induction studies? Induction potential is an important piece of the drug-drug interaction (DDI) component of an IND submission. Simply put, we...

The Japanese regulatory agent PMDA (Pharmaceuticals and Medical Devices Agency) recently published an official English translation of their final Drug Interaction Guideline...

About JCRB cell bank In addition to focus on preclinical ADME in vitro testing services and complementary products, XenoTech offers to our clients...

While liver and intestine are important in ADME, behavior in blood is also crucial. When an orally administered drug or...

The mechanisms of clearance for small molecule drugs and therapeutic proteins are fundamentally distinct and therefore therapeutic proteins are generally not...

As technology evolves to better meet needs in exploration of drug metabolism pathways and disease mechanisms, familiarization with appropriate and...

XenoTech has been working with and supplying reagents for the pre-clinical ADME field for well over two decades. Years of...

Not only can drug transporters affect the absorption and excretion of drugs, they can be involved in pharmacokinetic-based drug-drug interactions...

Over the past 25 years of performing ADME/DMPK/DDI contract research, we’ve learned some key strategies to maximize the efficiency and effectiveness...

XenoTech understands that a better future starts with our actions today, and encourages its global family to remain focused on...

In October 2017, the FDA released its much-anticipated draft guidance documents for drug-drug interaction (DDI) studies, which was finalized in...

The Pharmaceutical and BioScience Society (PBSS) hosted the workshop “Drug-Drug Interactions: Update on Risk Assessment, Clinical Evaluation and Regulatory Requirements” on October...

That is the question. . . Knowing the answer may save you time and money Good Laboratory Practices (GLP) are...

Brian Ogilvie, Ph.D., Vice President of Scientific Consulting at XenoTech, presented a case study on the importance of the hepatic OCT1...

Transporters are membrane-bound proteins that govern the passage of drugs into and out of cells. These gatekeeper proteins can be...

XenoTech is proud to have made contributions to the paper entitled, “Considerations from the IQ Induction Working Group in Response...

XenoTech offers bioanalytical services to support both internal groups and external clients. We have validated LC-MS/MS methods for human CYP markers, UDP...

CryostaX® hepatocytes are created using a patented process that produces unique single-donor cell pellets. This format allows scientists to easily pool primary...

The American Association of Pharmaceutical Scientists (AAPS) and U.S. Food and Drug Administration (FDA) co-sponsored the workshop “Drug Transporters in ADME:...

Cryopreservation and thawing of primary hepatocytes causes inherent damage to the cells. Traditional pooling methods require cells to undergo two separate cryopreservation...

XenoTech has patented technology that eliminates the need for the water baths that are traditionally required to thaw cryopreserved hepatocytes. By removing water...

Over the past two decades, we’ve received a lot of interesting requests for custom tissue preparations here at XenoTech. “We’ve...

Leader in pharmaceutical research and scientific collaboration Originally printed in the Fall 2017 Issue of NewsWave. XenoTech, LLC, which is...

Updated Nov. 6th, 2017 The FDA has released its long-awaited new draft guidance for industry on drug-drug interaction (DDI) studies....

The gastrointestinal wall is a significant site of first-pass metabolism for oral drugs, which is commonly associated with CYP450 and...

XenoTech is committed to furthering the knowledge surrounding hepatic diseases, which affects one out of four people worldwide, such as...

XenoTech is committed to furthering the knowledge surrounding hepatic diseases, such as nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis...

Understand which transporters are involved in a drug’s absorption, distribution & excretion Originally posted on Labiotech.EU How can you build the...

XenoTech recently fulfilled its largest order of human liver subcellular fractions to date. A large pharmaceutical customer ordered over 30,000...

On Thursday, April 23rd, XenoTech participated in “bring your child to work day”. At XenoTech, we are passionate about what...