Glossary

ADME/tox, an acronym, is a series of critical tests in drug discovery to characterize a compound's properties with respect to its Absorption by the intestine, Distribution to the organism, Metabolism by the liver, Excretion by the kidney, as well as its Toxicity. Most high-profile drug failures are caused by toxic side effects. Researchers are working to identify compounds with toxic properties far earlier in the drug-discovery process, before expensive clinical trials have begun, so they can focus their time and resources on developing only the safest and most promising drug candidates. Click here for more information.

Biomarker (sometimes referred to as a metabolomic biomarker) is a biochemical characteristic that can be used to diagnose and measure the progress of disease.

Discovery Partners – The National Institutes of Health (NIH) awarded Discovery Partners (DPI) a multi-year contract to set up and maintain a small-molecule repository to manage and provide up to one million chemical compounds to multiple NIH funded Screening Centers as part of the NIH Roadmap. The repository is being located at DPI's Chemistry Division, in San Francisco, California. Building upon the results of the Human Genome Project, the NIH Roadmap has been established to accelerate medical research progress in drug discovery. The ultimate goal of the repository is to offer public sector biomedical researchers access to hundreds of thousands of small organic molecules, which can be used as chemical probes to study cellular pathways in greater depth. Click here for more information.

FDA 21 CFR Part 11 – Also known as the electronic records and signature rule, FDA 21 CFR Part 11 is a U.S. Food and Drug Administration (FDA) regulation, enacted in 1997, that mandates compliance by pharmaceutical companies for generating and archiving test data electronically in perpetuity. Click here for more information.

Genomics is the comprehensive study of all the genes in a cell or organism, how they interact, and their function, based on knowing the organism's entire DNA sequence. The term genome is used to refer to all the DNA contained in a cell including both the chromosomes within the nucleus and the DNA in the mitochondria, in short, the complete set of genetic material necessary for life.

High Performance Liquid Chromatography (HPLC) is an analytical-chemistry-based tool for analyzing mixtures of chemical compounds. It is used to determine the amount of a chemical compound within a mixture of other chemicals, for example the exact amount of active pharmaceutical ingredient in a drug. The sample is dissolved in a solvent (like water or alcohol) and a detector measures response changes between the solvent itself, and the solvent and sample when passing through it. The electrical response is digitized and sent to a data system. Click here for more information.

Immunoassay – a test that uses the binding of antibodies to antigens to identify and measure certain substances. Immunoassays may be used to diagnose disease. Also, test results can provide information about a disease that may help in planning treatment (for example, when estrogen receptors are measured in breast cancer).

Metabolomic biomarker (sometimes referred to as a biomarker) is a biochemical characteristic that can be used to diagnose and measure the progress of disease, the effects of a treatment, or who may be predisposed to experience a harmful side effect from a drug. Click here for more information.

Metabolomics is the study of an organism's low-molecular weight molecules or metabolites (e.g., amino acids, peptides, lipids, carbohydrates) – chemical byproducts that result when a substance breaks down (metabolizes). By understanding and detecting metabolic differences, for example, between normal and diseased states, researchers hope to provide earlier and more precise diagnosis and prevention. In drug discovery and development, it may help us to understand how and when drugs work, interact, and cause side effects. It's also becoming increasingly important in applications from environmental toxicology and cell biology to plant biochemistry. Click here for more information.

Metabolite an organism's low-molecular-weight molecules (e.g., amino acids, peptides, lipids, carbohydrates) – biochemical byproducts that result when a substance breaks down (metabolizes).

Microplate-based biomolecular immunoassays – Typically performed using an optical-based technology (absorbance, fluorescence, or luminescence), microplate-based biomolecular immunoassays are tests designed to measure the activity or function of various large molecules such as proteins, antibodies, and nucleic acids (DNA or RNA). Many cellular functions can also be measured in this fashion. This is also called an "immunoassay" when it is used in diagnosing disease, for example. It's also useful in helping to plan an appropriate treatment strategy. Click here for more information.

National Institute of Allergy and Infectious Diseases (NIAID) has awarded a five-year contract to The Institute for Genomic Research (TIGR) to establish the Pathogen Functional Genomics Resource Center (PFGRC). The PFGRC is a centralized facility providing the research community with resources necessary to conduct functional genomics research on human pathogens and invertebrate vectors of infectious diseases. The PFGRC provides scientists with genomic resources and reagents such as microarrays, protein expression clones, genotyping and bioinformatics services. The PFGRC supports the training of scientists in the latest techniques in functional genomics and emerging genomic technologies. Click here for more information.

NIH Roadmap for Medical Research is a series of far-reaching initiatives designed to transform the nation's medical research capabilities and speed the movement of scientific discoveries "from the bench to the bedside." It provides a framework of the priorities the NIH must address in order to optimize its entire research portfolio and lays out a vision for a more efficient and productive system of medical research. Click here for more information.

Proteomics is the study of the set of proteins produced (expressed) by an organism, tissue, or cell, and the changes in protein expression patterns in health and disease, or in different environments and conditions.

Reagents are chemical substances that are used to produce a chemical reaction in order to measure, detect, or examine other substances.