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The Unique Ingredient Identifier (UNII) is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier linked to a substance's molecular structure or descriptive information and generated by the Global Substance Registration System (GSRS) of the Food and Drug Administration (FDA).
The GSRS is used to generate permanent, unique identifiers for substances in regulated products, such as ingredients in drug and biologic products. The GSRS uses molecular structure, protein and nucleic sequences and descriptive information such has taxonomic information to generate the UNII. The primary means for defining a chemical substance is by its two-dimensional molecular structure with complete stereochemistry captured as well. Proteins and nucleic acids are defined by their sequences and any modifications that may be present. Polymers are defined by their structural repeating units and physical properties such as molecular weight or properties related to molecular weight (e.g. viscosity). Structurally diverse material (e.g., botanicals), are defined by taxonomic information along with a part or fraction of the material.
The GSRS is a freely distributable software system provided by through a collaborations between FDA and NIH/NCATS. The GSRS was developed to implement the ISO 11238 standard which one of the core ISO Identification of Medicinal Product (IDMP) standards. The GSRS Board which governs the GSRS includes experts from FDA, European Regulatory Agencies, and the United States Pharmacopoeia (USP).
Bioinformatics is an interdisciplinary field that develops methods and software tools for understanding biological data. As an interdisciplinary field of science, bioinformatics combines biology, computer science, information engineering, mathematics and statistics to analyze and interpret biological data. Bioinformatics has been used for in silico analyses of biological queries using mathematical and statistical techniques.
Proteins are large biomolecules, or macromolecules, consisting of one or more long chains of amino acid residues. Proteins perform a vast array of functions within organisms, including catalysing metabolic reactions, DNA replication, responding to stimuli, providing structure to cells, and organisms, and transporting molecules from one location to another. Proteins differ from one another primarily in their sequence of amino acids, which is dictated by the nucleotide sequence of their genes, and which usually results in protein folding into a specific three-dimensional structure that determines its activity.
The National Center for Biotechnology Information (NCBI) is part of the United States National Library of Medicine (NLM), a branch of the National Institutes of Health (NIH). The NCBI is located in Bethesda, Maryland and was founded in 1988 through legislation sponsored by Senator Claude Pepper.
A nucleic acid sequence is a succession of base-pairs signified by a series of a set of five different letters that indicate the order of nucleotides forming alleles within a DNA or RNA (GACU) molecule. By convention, sequences are usually presented from the 5' end to the 3' end. For DNA, the sense strand is used. Because nucleic acids are normally linear (unbranched) polymers, specifying the sequence is equivalent to defining the covalent structure of the entire molecule. For this reason, the nucleic acid sequence is also termed the primary structure.
Structural bioinformatics is the branch of bioinformatics which is related to the analysis and prediction of the three-dimensional structure of biological macromolecules such as proteins, RNA, and DNA. It deals with generalizations about macromolecular 3D structure such as comparisons of overall folds and local motifs, principles of molecular folding, evolution, and binding interactions, and structure/function relationships, working both from experimentally solved structures and from computational models. The term structural has the same meaning as in structural biology, and structural bioinformatics can be seen as a part of computational structural biology.
A chemical database is a database specifically designed to store chemical information. This information is about chemical and crystal structures, spectra, reactions and syntheses, and thermophysical data.
The Structural Classification of Proteins (SCOP) database is a largely manual classification of protein structural domains based on similarities of their structures and amino acid sequences. A motivation for this classification is to determine the evolutionary relationship between proteins. Proteins with the same shapes but having little sequence or functional similarity are placed in different superfamilies, and are assumed to have only a very distant common ancestor. Proteins having the same shape and some similarity of sequence and/or function are placed in "families", and are assumed to have a closer common ancestor.
The DrugBank database is a comprehensive, freely accessible, online database containing information on drugs and drug targets. As both a bioinformatics and a cheminformatics resource, DrugBank combines detailed drug data with comprehensive drug target information. DrugBank has used content from Wikipedia. Wikipedia also often links to Drugbank.
KEGG is a collection of databases dealing with genomes, biological pathways, diseases, drugs, and chemical substances. KEGG is utilized for bioinformatics research and education, including data analysis in genomics, metagenomics, metabolomics and other omics studies, modeling and simulation in systems biology, and translational research in drug development.
Biomolecular structure is the intricate folded, three-dimensional shape that is formed by a molecule of protein, DNA, or RNA, and that is important to its function. The structure of these molecules may be considered at any of several length scales ranging from the level of individual atoms to the relationships among entire protein subunits. This useful distinction among scales is often expressed as a decomposition of molecular structure into four levels: primary, secondary, tertiary, and quaternary. The scaffold for this multiscale organization of the molecule arises at the secondary level, where the fundamental structural elements are the molecule's various hydrogen bonds. This leads to several recognizable domains of protein structure and nucleic acid structure, including such secondary-structure features as alpha helixes and beta sheets for proteins, and hairpin loops, bulges, and internal loops for nucleic acids. The terms primary, secondary, tertiary, and quaternary structure were introduced by Kaj Ulrik Linderstrøm-Lang in his 1951 Lane Medical Lectures at Stanford University.
Martindale: The Complete Drug Reference is a reference book published by Pharmaceutical Press listing some 6,000 drugs and medicines used throughout the world, including details of over 180,000 proprietary preparations. It also includes almost 700 disease treatment reviews. It was first published in 1883 under the title Martindale: The Extra Pharmacopoeia. Martindale contains information on drugs in clinical use worldwide, as well as selected investigational and veterinary drugs, herbal and complementary medicines, pharmaceutical excipients, vitamins and nutritional agents, vaccines, radiopharmaceuticals, contrast media and diagnostic agents, medicinal gases, drugs of abuse and recreational drugs, toxic substances, disinfectants, and pesticides.
Analyte-specific reagents (ASRs) are a class of biological molecules which can be used to identify and measure the amount of an individual chemical substance in biological specimens.
Numerous key discoveries in biology have emerged from studies of RNA, including seminal work in the fields of biochemistry, genetics, microbiology, molecular biology, molecular evolution and structural biology. As of 2010, 30 scientists have been awarded Nobel Prizes for experimental work that includes studies of RNA. Specific discoveries of high biological significance are discussed in this article.
The Conserved Domain Database (CDD) is a database of well-annotated multiple sequence alignment models and derived database search models, for ancient domains and full-length proteins.
This glossary of biology terms is a list of definitions of fundamental terms and concepts used in biology, the study of life and of living organisms. It is intended as introductory material for novices; for more specific and technical definitions from sub-disciplines and related fields, see Glossary of genetics, Glossary of ecology, Glossary of speciation, Glossary of botany, and Glossary of scientific naming.
The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012. It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics. It also creates the breakthrough therapy designation program and extends the priority review voucher program to make eligible rare pediatric diseases. The measure was passed by 96 senators voting for and one voting against.
The Dietary Supplement Health and Education Act of 1994 ("DSHEA"), is a 1994 statute of United States Federal legislation which defines and regulates dietary supplements. Under the act, supplements are effectively regulated by the FDA for Good Manufacturing Practices under 21 CFR Part 111.
Identification of Medicinal Products (IDMP) is a set of five ISO norms which has been developed in response to a worldwide demand for internationally harmonized specifications for medicinal products. IDMP provides the basis for the unique identification of medicinal products, it facilitates the activities of medicines regulatory agencies worldwide by jurisdiction for a variety of regulatory activities. IDMP is the base for the Marketing authorization of medicinal products in Europe. It requires the five ISO Norms being implemented in the Marketing Authorization Application process.
The term cosmetic packaging is used for cosmetic containers and secondary packaging of fragrances and cosmetic products. Cosmetic products are substances intended for human cleansing, beautifying and promoting an enhanced appearance without altering the body's structure or functions.
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