2026-02-26: DEUSG Virtual

 Summary

The meeting focused on updates and discussions regarding modeling options for inert and placebo products. Linda presented a revised proposal to model products with no active ingredients as medicinal product forms (MPFs) to address issues with excipient ingredients and preserve the class hierarchy. Yong provided feedback, suggesting the use of the "has active ingredient" attribute instead of creating a new attribute, to avoid potential logical classification issues. The team discussed the implications of these modeling choices and sought feedback for international alignment.

The team discussed changing the classification of HAS excipient ingredient to HAS ingredient as a supertype, but Linda expressed concerns about potential classification issues. Yongsheng suggested that setting the count of forming gradient to zero could resolve these problems. Guillermo explained that the clinical drug model was designed to align with IDMP standards, and changing the classification could create conflicts with international regulations and future implementations. The group agreed that creating a new attribute for HAS excipient or inactive ingredient would be the best approach, rather than using a generic HAS ingredient supertype.

The group discussed challenges with classifying products that contain no active ingredients or have unmodeled ingredients. Guillermo expressed concerns about using a count of zero active ingredients, as it could incorrectly classify products as having no active ingredients. Ian highlighted the importance of carefully defining "inert" excipients, as changes to formulations can affect drug bioavailability. Linda suggested focusing on products containing no active ingredients rather than using the term "inert." The discussion also touched on the benefits of being able to perform mathematical operations on the count of active ingredients for certain use cases.

The team discussed how to distinguish products with no active ingredients in the model, with Guillermo explaining that overloading attributes to mean multiple things has historically caused problems. Yongsheng suggested adding explicit content to differentiate products clearly stated as having no active ingredients, while Guillermo emphasized the need to maintain the counteractive ingredient attribute's original mission of helping classification and avoiding universal restrictions. The discussion concluded that while there's a need to signal inert products, there are billions of ways to do this, and the team should avoid overloading existing attributes that serve specific purposes.

The group discussed options for modeling dose forms and administrable dose forms, with Yong presenting three models: a nested model, a flat model, and an additional relationship model. Guillermo emphasized the need for consistency with international standards and proposed populating all dose form attributes to align with the DQM. The group agreed to aim for a decision by the April meeting, with Shane suggesting they could discuss the topic further in the next online meeting before then. They also touched on the need to address cross-border challenges and ensure consistent approaches across different extensions.

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