Health / Medical Topics

    Stability Product Identifier Terminology

    Definition 1

    Terminology developed to support Product Identifiers within the Stability Data Standards. (NCI Thesaurus)

    Definition 2

    This is the code for the official product name. For FDA implementation, only the "displayName" (i.e., the product name) is mandatory, the code values might be provided if available (e.g., when used in other submissions like SPL). For NDA this is a new identifier. For ongoing studies the identifier should be identical to an already submitted code, so that a unique relationship can be established. (Food and Drug Administration)




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