DRUG LABELING TOOL

摘要

A tool for aiding a user author labels for drugs. The tool receives inputs that define requirements for a label, or aggregated requirements for a set of related labels. The requirements may be derived from inputs specifying values of label attributes and then be used to identify fields to appear in each of one or more labels to be generated. Information on fields may be used to dynamically render an interface through which a user may specify text strings to appear in each field when label text is generated. Input elements of the interface may be populated with lists of options identified based on the requirements. The requirements may also be used in generating similar labels and assessing the impact of changes, such as to regulatory requirements. The tool may be particularly useful for authoring labels for clinical trials in which multiple label formats for multiple countries may be generated.

主权项

1. A method of generating a label for a drug, the method comprising:
receiving first user inputs identifying values of a plurality of label attributes; based on the values of the plurality of label attributes, determining a plurality of label fields; rendering on a display device an interface based on the determined plurality of fields, the interface comprising a plurality of input areas, each of the input areas corresponding to a respective label field of the plurality of determined label fields; receiving second user inputs through the plurality of input areas, each received second user input specifying a text string associated with a respective label field of the determined plurality of label fields; and with at least one processor, generating label text based, at least in part, on the received second user input.