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An example of the source EDQM pharmaceutical dose form terminology is shown below, taken from the Standard Terms browser:
EDQM Term, Definition, and Comment
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Exclusion statements may be found either in the main Definition (as in the first example) or in the Comment section (as in the second example below). These are provided not as explicit exclusion from a higher level concept but as implementation guidance” for marketing authorisation applicants to support them when selecting a PDF to describe their product. This means that, despite these exclusion statements. , an EDQM higher-level PDF concept is semantically equivalent to a SNOMED CT higher-level (grouper) concept PDF.
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In the concept below "to obtain a local effect" is stated in the definition. The definition of a PDF is concerned with it being the thing that "formulates or encapsulates or contains the active and inactive ingredient substances either at the point of supply (the manufactured dose form) or at the point of administration (the administrable dose form)"; therefore there should be no consideration of what happens to the active substance(s) once the administration has been made and no consideration of what or where their effect will occur. It is not possible to state accurately for any one PDF whether its effect (either therapeutically desired or undesired) will be "local" or "systemic"; for example, there are oral tablets that have no systemic effect (e.g. nystatin). Therefore, even if "for local effect" (or "for systemic effect") is part of either the definition or the comment for an EDQM PDF concept, it will not be deemed part of the semantic of the concept for mapping.
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