How Granular Can a Dose Form Be Described? Considering EDQM Standard Terms for a Global Terminology

The aim was (1) to analyse the features of EDQM terminology, (2) formulate proposals for minor changes and (3) create a small ontology dose forms, based on characteristics EDQM, suitable alignment with other form terminologies. 428 Pharmaceutical Dose Forms (PDF) (“human veterinary” only) were extracted from Standard Terms database. A quantitative qualitative analysis textual definitions terms conducted. Through an unique combinations different sets descriptors characteristics, built in three levels. For 143 transformable PDFs, administrable made explicit, 121 requiring only one transformation 22 multiple transformations, which 10 include “no transformation”. Different levels aggregations PDFs tested 4 analyses, ranging 206 383 combinations. An Webprotégé created higher-level concepts (based intended site characteristics) 69 intermediate-level (newly created) accommodate EDQM. Form terminology is granularity, defining forms medicinal products, enable fair comparison similar global identification products (IDMP). Recommendations improvements simple are proposed.