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Drug-induced Liver Injury: Development of a MILLIPLEX® Map Multiplexed Assay Panel for Emerging Biomarkers

Merck KGaA, Darmstadt, Germany

Drug-induced Liver Injury: Development of a MILLIPLEX® Map Multiplexed Assay Panel for Emerging Biomarkers

24 Nov 2015

Drug-induced liver injury (DILI) is the primary adverse event that results in withdrawal of drugs from market. The liver is a multifunctional organ. As drugs may cause liver injury through various mechanisms, measurement of multiple biomarkers is required to ensure that the potential for hepatotoxicity is identified early in drug development. This application note describes a Luminex® bead-based multiplex immunoassay that can simultaneously measure PSTC-investigated hepatotoxicity biomarkers, liver-type arginase 1 (ARG1), α-glutathione-S-transferase (GST-α), 5’nucleotidase (5NT) and sorbitol dehydrogenase (SDH), as well as the recently discovered biomarker, glutamic-oxaloacetic transaminase 1 (GOT1), in the blood.

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Merck KGaA, Darmstadt, GermanyCompany website

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ADME-ToxicologyADME-toxicology (ADME-Tox) studies are used in pharmacology and pharmacokinetics to assess the activity/toxicity of drugs <i>in vivo</i> or <i>in vitro</i>. Find bioassays for absorption, distribution, metabolism, and excretion of drug molecules including cytotoxicity, transporter/permeability, metabolism and activity assays as well as hepatocytes and cell lines for ADME. Find the best ADME-toxicology products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.BiomarkersBiomarkers are biological markers which can be measured and evaluated to indicate a biological state. The use of biomarkers in research and diagnosis can indicate a normal or disease state or drug response of cells / tissues. Biomarkers include genetic markers, cell surface markers such as antigens, antibodies or receptors and secreted molecules such as cytokines. An assay system is required for identification of biomarkers. :RegulatoryPharmaceutical regulations impact on all areas of drug development, manufacture and control and supply. Services are provided from the early stages of drug development and clinical trials through to dossier submission, approval and marketing. Regulatory also includes submission of analytical studies from the pharmaceutical product and safety. HepatocytesHepatotoxicityDrug TestingIt is essential to test the efficacy and toxicity of drugs at every stage of their development to ensure that a pharmaceutical product is fit for purpose and safe for use before reaching the stage of mass production and distribution.ImmunoassayImmunoassays are laboratory tests that utilize antibody-antigen interactions to detect specific substances. They are widely used in diagnostics for detecting diseases, drug testing, and environmental monitoring. These assays offer rapid, sensitive, and precise detection of biomarkers, making them invaluable in clinical and research labs. Browse our peer-reviewed product directory to compare immunoassay systems, read user reviews, and get pricing directly from manufacturers.Blood AnalysisThe analysis of blood is vital for many areas of life sciences and forensic investigations. Blood samples can be tested for a number of different reasons such as diagnosis, glucose levels, cholesterol and drug testing.Biomarker DiscoveryClinical biomarkers refer to substances related to known medical conditions that can be accurately measured <i>in vitro</i>. Biomarkers can be used to diagnose presence of a disease and indicate disease severity. The discovery of new biomarkers is incredibly valuable in the field of diagnostics.

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