'BoSS Clinical Drug' Concept in Drug Model

I believe we addressed this during our meeting in Oslo, Shane Byrnes, and I agree that we need broader, more general Clinical Drug (CD) concepts.

In AMT, the equivalent CD-level concepts include the active ingredient (to enable subsumption of modified forms) and is based on the base form of the substance unless the salt form is considered clinically significant. This can be a bit tricky, but perhaps if we gather data from all the NRCs on which salt forms are considered clinically significant and which are not, we could create more general CD concepts in the international edition where at least one NRC considers the salt not clinically significant.

These views may evolve over time, but the idea is that the CD layer would be broad enough to accommodate the various extensions where it is currently too narrow for most of them.

This raises two key questions:

1. What should be done with the existing, more specific CD concepts?

2. Is everyone comfortable with the new, more general CD concepts subsuming the existing specific ones?

For the first point, I think it makes sense to leave the existing concepts in place. NRCs can choose to use them based on their own assessment of clinical significance. If, in the future, there’s consensus that certain salt forms are not clinically significant, those specific CDs could potentially be retired after sufficient consultation. But for now, removing them would be difficult and would require extensive discussion.

On the second point, I actually think subsumption of the more specific concepts by general ones is the right outcome. I raise it only because there’s been considerable effort in the past to prevent CDs from subsuming one another, which seemed to be a concern for some. Personally, I don’t see it as an issue - in fact, I think it’s a natural and correct result.

What do we need to do to move this ahead?