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The GSRS is used to generate permanent, unique identifiers for substances in regulated products, such as ingredients in drug and biological products. The GSRS uses molecular structure, protein and nucleic sequences and descriptive information to generate the UNII. The preferred means for defining a
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is readily available. Nucleic acids are defined by their sequences and by any modifications that may be present. In the case of proteins only end-group modifications will be uniquely identified, along with any other modifications that are essential for activity. This is because of the inherently
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Peryea, Tyler; Southall, Noel; Miller, Mitch; Katzel, Daniel; Anderson, Niko; Neyra, Jorge; Stemann, Sarah; Nguyễn, Ðắc-Trung; Amugoda, Dammika; Newatia, Archana; Ghazzaoui, Ramez; Johanson, Elaine; Diederik, Herman; Callahan, Larry; Switzer, Frank (November 10, 2020).
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in ISO 11238 and ISO DTS 19844. UNIIs are non-proprietary, unique, unambiguous, and free to generate and use. A UNII can be generated for substances at any level of complexity, being broad enough to include "any substance, from an atom to an organism."
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heterogenous nature of proteins. Therefore, two different protein substances can share the same UNII and yet have no biosimilarity or therapeutic equivalence. Polymers are defined by their structural repeating units and
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chemical substance is by its two-dimensional molecular structure since it is pertinent to a substance's identity and information regarding a substance's
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standards. The GSRS Board which governs the GSRS includes experts from FDA, European
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245:"Global Substance Registration System: consistent scientific descriptions for substances related to health"
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89:). Structurally diverse materials are inherently heterogenous preparations from natural materials such as
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The GSRS is a freely distributable software system provided through a collaboration between the FDA, the
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Substance
Registration System | Unique Ingredient Identifier (UNII) - Food & Drug Administration
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110:(EMA). The GSRS was developed to implement the ISO 11238 standard which is one of the core ISO
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FDA identifier in the Global
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National Center for
Advancing Translational Sciences
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411:. You can help Knowledge by
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108:European Medicines Agency
138:Methadone hydrochloride
407:-related article is a
249:Nucleic Acids Research
57:structurally diverse
329:"ISO/TS 19844:2018"
262:10.1093/nar/gkaa962
255:(D1): D1179–D1185.
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309:. October 20, 2017
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49:nucleic acid
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452:Categories
199:References
191:059QF0KO0R
179:7YNJ3PO35Z
167:S88TT14065
155:UC6VBE7V1Z
143:229809935B
271:1362-4962
150:Methadone
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289:33137173
174:Hydrogen
122:Examples
81:such as
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361:fda.gov
280:7779023
224:fda.gov
118:(USP).
94:extract
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162:Oxygen
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132:UNII
91:plant
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369:2020
340:2020
315:2020
285:PMID
267:ISSN
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