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

Featured Application: This work will inform the revision process of the ISO Standard ISO 11239:2012 on dose forms of medicinal products and provide tools for training and supporting experts in the pharmaceutical industry and in regulatory affairs, during the standardization of national drug dictionaries to the global terminology for dose forms of EDQM. The aim was (1) to analyse the features of the EDQM terminology, (2) to formulate proposals for minor changes and (3) to create a small ontology of dose forms, based on characteristics of EDQM, and suitable for alignment with other dose form terminologies. The 428 Pharmaceutical Dose Forms (PDF) ("human and veterinary" only) were extracted from the EDQM Standard Terms database. A quantitative and qualitative analysis of the textual definitions of the terms was conducted. Through an analysis of unique combinations of different sets of descriptors and characteristics, a small ontology was built in three levels. For the 143 transformable PDFs, the administrable dose form was made explicit, with 121 requiring only one transformation and 22 multiple transformations, of which 10 include "no transformation". Different levels of aggregations of the 428 PDFs were tested in 4 analyses, ranging from 206 to 383 unique combinations. An ontology in Webprotégé was created of 22 higher-level concepts (based on the intended site characteristics) and 69 intermediate-level terms (newly created) to accommodate the 428 PDFs of EDQM. EDQM Dose Form terminology is suitable terminology in terms of granularity, for defining dose forms of medicinal products, to enable fair comparison of similar medicinal products, and global identification of medicinal products (IDMP). Recommendations for minor improvements and a simple ontology for dose forms are proposed. [ABSTRACT FROM AUTHOR]