January 2019

Disease-State Test Systems

Author: Dr. Chris Bohl, Michael Millhollen Posted: 13 January 2019

Sekisui XenoTech has been working with and supplying reagents for the pre-clinical ADME field for well over two decades. Years of acquiring and banking human liver tissues for the production of hepatic subcellular fractions and hepatocytes has allowed us to be able to identify and produce interesting and novel hepatic disease state test systems for research groups. These test systems form the basis for our Research Biobank. We also partnered with the National Institute of Biomedical Innovation to distribute the Japanese Collection of Research Bioresources (JCRB) Cell Bank’s extensive selection of cell lines to North America and Europe...

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Considerations for the Conduct of In Vitro Drug Transporter Assays

Author: Greg Loewen, Andrea Wolff, Michael Millhollen Posted: 11 January 2019

Not only can drug transporters affect the absorption and excretion of drugs, they can be involved in pharmacokinetic-based drug-drug interactions (DDI), impacting distribution into tissues as well as the overall exposure of the drug. As a result, regulatory bodies such as the FDA, EMA and PMDA recommend studying the potential of NCEs to be inhibitors or substrates of drug transporters in vitro in order to better understand the ADME and DDI potential of drugs and help determine if clinical studies should be performed. The design and scope of in vitro transporter studies can vary depending on the physicochemical properties and major route(s) of excretion of the drug and should be considered when designing and performing in vitro studies that will support a new drug application (NDA) or decisions to run clinical DDI studies...

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5 Keys to Set Your Contract Research Organization (CRO) Collaboration Up for Success

Author: Kelsey Pigg, Michael Millhollen Posted: 07 January 2019

Over the past 25 years of performing ADME/DMPK/DDI contract research, we’ve learned some key strategies to maximize the efficiency and effectiveness of our clients’ studies. Here are a few critical considerations that will help you ensure that your studies are completed on time and deliver the most accurate, relevant data...

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