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FDA-TRACK Research Glossary

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Term Definition 
antimicrobialA substance that kills or inhibits the growth of microorganisms such as bacteria or fungi
ArrayTrackArrayTrack is a product designed and produced by NCTR and available to the public. It provides an integrated solution for managing, analyzing, and interpreting microarray gene expression data; it provides a rich collection of functional information about genes, proteins, and pathways for biological interpretation.
assay A test or procedure to determine the components, characteristics or composition of a substance 
bacterial isolatesA pure strain of bacteria which has been seperated from a mixed bacterial culture 
bio-chemicalOf or relating to biochemistry; involving chemical processes in living organisms
bioinformatics Application of statistics and computer science to the field of molecular biology
Biological Assay (bioassay) Procedures that determine the composition of or effect of a substance on a living organisms 
biological dose-response models A predictive model that describes biological processes at the cellular and molecular level linking the target organ dose to the adverse effect.  
biomarker A measurable characteristic that can be used as an indicator of a particular disease or some other physiological state of an organism 
Bioterrorism Terrorism involving the intentional release or dissemination of biological agents (bacteria, viruses, or toxins), that may be in a naturally-occurring or in a human-modified form 
Cancer mode of Action Process by which a chemical causes cancer 
carcinogen  Any substance or radiation that is an agent directly involved in causing cancer 
carcinogenic Having the characteristic of being an agent directly involved in causing cancer 
Cardiotoxicity Condition in which there is damage to the heart muscle 
compound Pure chemical substance consisting of two or more different chemical elements
Concept Paper A description of a planned research activity that is submitted in advance of the submission of a protocol 
confocal microscope Optical imaging technique used to increase optical resolution and contrast of a microscopic image 
dendrimerRepeatedly branched, roughly spherical large molecules
Document Tracking System Internal tracking system for Center Director approval of external publications 
electrophoretic  A method of separating substances based on the rate of movement of each component in a colloidal suspension while under the influence of an electric field. 
entericOf, relating to, or being within the intestine
Ethylene Oxide Study The study to determine the health effects of inhaling ethylene oxide, a gas used in manufacturing organic compounds and as a fumigant, fungicide, and sterilizing agent; it is highly irritating to the eyes and mucous membranes and is carcinogenic. 
gene expression Process by which genes produce a functional gene product 
genomeThe entirety of an organism's hereditary information, including both the genes and the non-coding sequences of the DNA/RNA
Genomics Study of all the genes (and gene products—RNA and proteins) as a dynamic system, over time, determining how they interact and influence biological pathways, networks, and physiology.
genotype Genetic makeup of a cell, an organism, or an individual  
Hepatocytes Cells of the main tissues of the liver 
HepatotoxicityChemical-driven liver toxicity 
HeterozygousA cell is said to be homozygous for a particular gene when two different alleles (an alternative version of a gene) of a gene are present on both homologous chromosomes
High density genomic microarray Multiplex nucleic acid probe technology used in molecular biology and in medicine 
HomozygousA cell is said to be homozygous for a particular gene when identical alleles (an alternative version of a gene) on a gene are present on both homologous chromosomes. The cell or organization in question is called a homozygote. True breeding organisms are always homozygous for the traits that are to be held constant.
In-vivo Within a living organism 
IsolatesDNA or proteins that have been separated in pure form from a combined mixture
Janus Janus is a electronic warehouse for storing and organizing structured scientific data about regulated products in support of regulatory decision-making. With the use of Janus, scientists are able to acquire, validate, integrate, and extract standardized, structured data. Janus is used by scientists across FDA. 
laser confocal microscopyA technique for obtaining high-resolution optical images with depth selectivity.
Liquid Chromatography/Mass Spectrometry (LC/MS) LC/MS is an analytical chemistry technique that combines the separation capabilities of liquid chromatography and mass measurement capabilities of mass spectrometry. The technique can be used for detection, identification, and quantification of single or mixtures of chemicals or biomolecules extracted from biological samples. 
liquid scintillating countingAn analytical technique which is defined by the incorporation of the radiolabeled analyte into uniform distribution with a liquid chemical medium capable of converting the kinetic energy of nuclear emissions into light energy
mastitisInflammation of the breast tissue
metabolites Products of the chemical reactions that occur in living organisms
microbiota A complex population of different microbes which interact and live together
MicroRNA MicroRNAs have been shown to play an integral role in numerous biological processes including the immune response, cell-cycle control, metabolism, viral replication, stem cell differentiation and human development. 
modulation Regulating according to measure or proportion 
Multidrug Resistance Protein 1 (MDR-1)Responsible for maintaining the blood-brain barrier to certain drugs. A deletion mutation in this gene is responsible for the sensitivity to ivermectin observed in Collie dogs and related breeds.
nanoparticles A very small (sized between 1 and 100 nanometers) particle 
neurotoxicity Occurs when the exposure to natural or artificial toxic substances, which are called neurotoxins, alters the normal activity of the nervous system in such a way as to cause damage to nervous tissue. 
nuclease interference studies Studies that focus on hindering the degradation of nucleic acid (DNA and RNA) 
nucleotide Molecules that, when joined together, make up the structural units of RNA and DNA 
"omics" technologies Omics technologies are high throughput technologies used to analyze various kinds of macromolecules, simultaneously; for example, transcriptomics measures many transcripts, proteomics measures many proteins and metabolomics measures many metabolites. High throughput technologies are large scale methods to purify, identify, and characterize DNA, RNA, proteins and other molecules. These methods are usually automated, allowing rapid analysis of very large numbers of samples. 
Oxidative Stress The harmful condition that occurs when there is an excess of free radicals, a decrease in antioxidant levels, or both, resulting in (often) irreversible cellular damages. 
pathogen 

1.  An microbial agent that causes a disease 

2. Microbes that cause a diseased state in a host (i.e., virus, bacteria, parasites)

pathogenicity The ability of an microbial agent to produce an infectious disease in an organism 
pattern-recognition algorithms The assignment of some sort of output value (or label) to a given input value (or instance), according to some specific algorithm 
Personalized Medicine A process where the optimal medicine is delivered to a patient based on the patient's individual genetic makeup. 
Personalized Nutrition A process where an individual’s nutrient intakes throughout the course of life using evidence-based information is optimized. 
Pharmacogenetics The convergence of pharmacology and genetics dealing with genetically determined responses to drugs. 
PharmacogenomicsThe whole genome applciation of pharmacogenetics, which examines the single gene interactions with drugs.  Pharmacogenomics aims to develop rational means to optimise drug therapy, with respect to a patient's genotype, to ensure maximum efficacy with minimal adverse effects.
PharmacokineticsThe study of mechanisms of absorption and distribution of an administered drug, the rate at which a drug action begins and the duration of the effect, the chemical changes of the substance in the body (e.g. by enzymes) and the effects and routes of excretion of the metabolites of the drug.
phenotypeAn organism's observable characteristics or traits: such as its morphology, development, biochemical or physiological properties, behavior, and products of behavior.
Phosphatidylinositol Glycan Class A (Pig-A Gene) A housekeeping gene located on the short arm of the X chromosome gene which renders the cells unable to produce the glycosyl-phosphatidylinositol (GPI) anchor, against a background of reduced bone marrow activity 
plasmid 

1. A DNA molecule that is separate from, and can replicate independently of, the DNA which contains biological information of heredity, chromosomal DNA. 

2. Circular segments of DNA that are external to chromsomal DNA and are easily transferable between cells.

polymerase chain reaction (PCR)The amplification of a specific DNA sequence, termed target or template sequence, that is present in a complex mixture, by adding two or more short oligonucleotides, also called primers, that are specific for the terminal or outer limits of the template sequence. The template-primers mixture is subjected to repeated cycles of heating to separate (melt) the double-stranded DNA and cooling in the presence of nucleotides and DNA ploymerase such that the template sequence is copied at each cycle.
PolymorphismHaving multiple alleles (an alternative version of a gene) within a population, usually expressing different phenotypes (an organism's observable characteristics or traits)
protein toxins A toxin that inhibits protein synthesis (ex. Ricin and Abrin) or a protein which is toxic
Proteomics The study of all proteins produced by a cell or organism that are measureable within the cell of origin or body fluids. 
protocol A description of a study's objectives, approach, design, and procedures 
radiolabelTo tag a hormone, enzyme, or other substance with a radioactive tracer.
Range-finding study A study to determine the correct doses to use to get certain drug effects 
Risk Assessments Assessment to determine effects of exposure of a sustance to humans 
serotype (also servovar)A group of closely related microorganisms distinguished by a characteristic set of antigens.
Single Nucleotide Polymorphism (SNP)A DNA sequence variation occurring when a single nucleotide-A, T, C, or G- in the genome (or other shared sequence) differs between members of a species (or between paried chromosomes in an individual). For a variation to be considered a SNP, it must occur in atleast 1% of the population.
Strain AnalysisAnalysis of a segment of DNA/biological material.
substrates The surface a plant or animal lives upon (one of several definitions for this term)
Systems-Biology A holistic approach for studying biological systems. 
Toxicokinetic Studies Toxicokinetic studies are concerned with the change in concentration of the chemical or a metabolite with time in blood/plasma or other tissue. 
Toxicology A branch of biology, chemistry, and medicine concerned with the study of the adverse effects of chemicals on living organisms. It is the study of symptoms, mechanisms, treatments and detection of poisoning, especially the poisoning of people. 
virulence The degree to which a microbial agent causes disease

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