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The IDMP-O term definitions and terms inconsistency need to be changed #621

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linikujp opened this issue Aug 5, 2024 · 1 comment
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@linikujp
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linikujp commented Aug 5, 2024

Some of the central terms in IDMP-O, like “substance” or “medicinal product” are labelled as such, but are actually referring to the substance specification or medicinal product specification which describe the substance or medicinal product. The definitions of IDMP-O terms did not clearly specify when the term is associated with Specification of the things. For example, the definition of "active ingredient without basis of strength" refers to the role played by the "Specification" substance , rather than the "physical substance". However, the definition says "role of a substance present in a currently or previously marketed drug product indicating that it is or becomes pharmacologically active once delivered to patients whose basis of strength cannot be specified", where the use of "substance" alone can introduce confusion of thinking the "substance" as a physical entity.

Therefore, what follows identify changes dealing with disambiguating between physical entities and specifications referring to them, where the initial distinction is not clearly made in the original definition.

There are 14 patterns identified in 96 terms needing definition changes. Of course, the 14 patterns are somehow general, and sometime will need to be tweaked and adapted to the context and definition. In some cases, the axioms may seem to also be mixing between reference to the physical entity and the specification, hence group 7, which suggests to check the axioms for the corresponding class.

Below are the 14 groups of patterns of change suggestions, which facilitate making changes pragmmarically. (see IDMP-O classes_changePatterns.txt for the list of 96 terms associated with the grouping showing below)

#Group 1 changes: from “substance” to “substance specification specifying a physical substance”

#Group 2 changes: from “substance” to “physical substance”

#Group 3 changes: from “medicinal product” to “physical medicinal product”

#Group 4: circular

#Group 5: from “package items” to “package items specifications”

#Group 6: from “substance” to “substance specification”

#Group 7: check axioms

#Group 8: from “gene” to “gene specification”

#Group 9: from “pharmaceutical product” to “pharmaceutical product specification”

#Group 10: from “pharmaceutical product” to “physical pharmaceutical product”

#Group 11: from “molecular structure” to “physical molecular structure”

#Group 12: from “substance” to “a physical substance which is specified by a substance specification”

#Group 13: from “substance” to “substance specification or physical substance”

#Group 14: add “specification for” at the beginning

=== Note: this is based on the Pistoita tech coordination call on July 26, 2024 ===
The definition checking and suggestions were provided by Giaocomo de Colle (@giacomodecolle) and Asiyah Lin.

@mereolog
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mereolog commented Aug 9, 2024

I would suggest splitting this issue into several smaller/more detailed ones: preferably one for each group or at least separating out Group 4, Group 7, and the rest.

This would simplify the discussion and allow for smaller pull requests.

@mereolog mereolog added this to the Release 1.3.0 milestone Aug 9, 2024
@mereolog mereolog removed this from the Release 1.3.0 milestone Sep 26, 2024
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