## 2 Materials and Methods  
The EDQM Standard Terms database of dose forms is a publicly available database, that is accessible with an application programming interface (API) procedure, after login, free of charge, at the website of the European Pharmacopoeia (Ph. Eur), where a full description is available [16]. Data were extracted from Version 1.2.0--28 January 2019 [17]. The database of dose forms contains 562 single Pharmaceutical Dose Forms (PDF), pertaining to the human and veterinary domain. We did not consider in this analysis the 54 combined PDF (combinations of pharmaceutical dose forms of two manufactured items to be transformed into one pharmaceutical product in one administtable dose form) and the 70 Combined Terms (combinations of administtable dose forms and container). The PDFs pertaining only to the veterinary domain (\(n\) = 79), as well as the PDFS with the status of rejected (\(n\) = 23) or deprecated (\(n\) = 27) were excluded, leaving a final of 428 single current PDFs, for \"human and veterinary use\" in the analysis. These 428 PDFs with their definitions, descriptors, characteristics, and tags, were extracted from the EDQM Standard Terms database, using the dedicated API with the version of EDQM Standard Terms database [STD] of 2021-03-17 09:52:21. The data were stored in an MS excel file (see Supplementary File/List1-ST) and in a PostgreSQL relational database. First, a quantitative and qualitative analysis of the EDQM Terminology with its PDFs for manufactured items and administrative dose forms for pharmaceutical products was conducted, together with an analysis of the textual definition; the two descriptors (state of matter, basic dose form) of the pharmaceutical dose form and of the administtable dose form, and the value sets of the 4 characteristics (Release characteristics, Transformation, Intended Site, Method of Administration). PDFs for which a transformation was needed or possible were identified and counted, as well as PDFs with more than one value for method of administration (multiplicity). Second, the congruence between the textual definition and the combined values of the characteristics was checked by the three authors separately. In case these were considered not in accordance with the textual definition, the PDF was discussed until consensus was reached: the combination of characteristics was compatible with definition; contained less elements than in the definition, or more elements than in the definition. Third, a critical analysis was performed, with identification of potential problems or targets for improvement, with the formulation of potential approaches to remediation. A new characteristic was created, to indicate whether or not the PDF was intended for systemic effect. Consequently, a new MS Excel worksheet and PostgreSQL database was constructed with the proposals for remediation implemented. For every line of the 428 PDFs extra columns for administtable dose forms were added, to make the administtable dose form (and its state of matter and basic dose) explicit, in case of transformation (see Supplementary File/List5-basicFile). A first check of the appropriateness of the proposed changes was made by a clinical pharmacologist (RVS) and an EDQM expert (CJ, see acknowledgements). Fourth, an analysis was performed of different sets of the four descriptors (state of matter and basic dose form for PDF and for ADF) and the four characteristics of the PDFs. PDFs with identical values of descriptors and characteristics were grouped. Four different sets of descriptors and characteristics were analysed. These unique combinations, constructed mechanically by selecting different combinations of the characteristics, were then analysed qualitatively for internal consistency and relevance for granularity. Classes were split in case of PDFs with different rules for strength expression. Classes were split to obtain classes which were homogeneous with regard to systemic effect.