Protocol for a Validation Study of an Ontology of Administrable Dose Forms of Medicinal Products

Administrable dose form can be obtained after (no-)transformation from pharmaceutical dose form. Building on the creation of a small ontology of 428 pharmaceutical dose forms from EDQM to support alignment with other dose form ontologies (SNOMED-CT, RxNorm), the present study is focused on a simple ontology of 308 administrable dose forms, 27 Intended Sites and an intermediary level of 65 dose form groupers. The ontology was created after 432 pharmaceutical dose forms, 65 combined pharmaceutical dose forms and 73 combined terms were linked by EDQM to administrable dose forms during the UNICOM project. The article describes these resources, the resulting ontology, the differences between its top-level concepts and the source's. It presents the protocol for a validation study through expert review, as a preparation for use case studies.