Skip to content
New issue

Have a question about this project? Sign up for a free GitHub account to open an issue and contact its maintainers and the community.

By clicking “Sign up for GitHub”, you agree to our terms of service and privacy statement. We’ll occasionally send you account related emails.

Already on GitHub? Sign in to your account

change "investigational molecular entity" to "investigational substance" #38

Open
linikujp opened this issue Jun 10, 2021 · 1 comment
Labels
enhancement New feature or request

Comments

@linikujp
Copy link
Collaborator

linikujp commented Jun 10, 2021

The substance is wider than the molecular entity, for example, a Ginseng mixture under investigation is not a molecular entity, but a molecular entity aggregate. We incline to use a term "substance" instead of "molecular entity aggregate", which is defined in ISO 11238 standard by FDA, related with the GRSR (https://gsrs.ncats.nih.gov/). We need to check where the substance will be in BFO, comparing to the molecular entity aggregate.
[Discussed by Asiyah Lin and Leon Li on CTO call 6/10/2021]

@linikujp linikujp added the enhancement New feature or request label Jun 10, 2021
@linikujp
Copy link
Collaborator Author

linikujp commented Jul 7, 2021

Discussed on 07/07/2021
NCIt term substance : _Any matter of defined composition that has discrete existence, whose origin may be biological, mineral or chemical. -> this is the same definition as the ISO 11238 definition.
substance vs. drug. drug is a product, and substance can be anything - chemical, additives, dietary ingredient.

However, this investigational substance does not cover investigational device. The device has part substance. The term used in Europe " investigational medicinal product" maybe a class covers both substance and device. This is for another issue.

Conclusion drawn by the group discussion: All members agree to use "investigational substance."

Sign up for free to join this conversation on GitHub. Already have an account? Sign in to comment
Labels
enhancement New feature or request
Projects
None yet
Development

No branches or pull requests

1 participant