2025-11-20: DEUSG Virtual

Opening

2 min

Shane

Welcome & Notification of Recording

General Items:

• Meeting Recordings are saved for 50 days post meeting. Proposal to add AI summary of meetings to aid look-back (will be noted as AI generated).

• Proposal to push DEUSG calls out by 60 mins.

• 2026 Early Visibility Notifications Page is now available: 2026 Early Visibility Release NotificationsPreview

Less Granular Clinical Drug

15 min

Guillermo

Update on examples & analysis.

Open

Mapping of Modelling Variation in precisely clinical drugs - Guillermo

Patches/Vaginal Ring Strength Representation

15 min

Karen / Yong

How to represent reservoir size and release rate.

Proposal is to represent in Extensions.

Open

Example of ESTRING 7.5 microgram/24 hours from MHRA

Updates from Yong pre-meeting: Regarding the modeling of patches, I agree that there is no single ideal solution. The decision to use presentation strength is a pragmatic choice to prevent confusion with concentration strength normalization. To represent these products in extensions, a two-role group solution appears necessary to capture both the release rate and the total quantity of the active ingredient. One role group would represent the release rate (e.g., 7.5 microgram/24 hour), and the second would represent the total amount per unit (e.g., 2 mg/1 patch).

Substances Project Update

5 min

Monica

Brief update on substances project

Substances Co-ordinationPreview

Adding |Dose form after transformation| to the Dose form concept model

10 min

Yong

Continuation of discussion from Nov 6, 2025

Specificity of target value to new axiom:

• Basic dose form versus pharmaceutical dose form (e.g. solution versus oral solution versus rectal solution?)

PDFs with Transformations = 96

< 736542009 |Pharmaceutical dose form (dose form)| : 736473005 |Has dose form transformation (attribute)| != 761954006 |No transformation (transformation)|

Updates from Yong pre-meeting: On the subject of the dose form attribute, I suggest we add a text definition for `736473005 |Has dose form transformation (attribute)|` and update the Editorial Guide accordingly. This definition could state that “dose transformation” refers to the process where a manufactured medicinal product (manufactured item/dose form) requires further manipulation or alteration by a healthcare professional or patient before administration. This is aligned with IDMP and represents the manufactured dose form that requires transformation before administration. 385223009 |Powder for conventional release solution for injection (dose form)| is currently defined in the release.
=== 1209021002 |Powder for conventional release solution for infusion and/or injection (dose form)| :
    736476002 |Has basic dose form (attribute)| = 739005008 |Powder (basic dose form)|,
    736474004 |Has dose form intended site (attribute)| = 738984000 |Parenteral (intended site)|,
    736475003 |Has dose form release characteristic (attribute)| = 736849007 |Conventional release (release characteristic)|,
    736473005 |Has dose form transformation (attribute)| = 736853009 |Dissolve (transformation)|,
    736472000 |Has dose form administration method (attribute)| = 740685003 |Inject (administration method)|New attribute and remodeling
=== 1209021002 |Powder for conventional release solution for infusion and/or injection (dose form)| :
    Has basic dose form = |Powder|
    Has dose form after transformation = |Conventional release solution for injection (dose form)|
    Has dose form transformation = |Dissolve|

The proposed alternative is not simply adding an additional attribute to the international model. This is a significant change to the existing dose form model. The administration method and release characteristic are embedded into the dosage form after transformation. This will require careful analysis and evaluation. In particular, the “dose form after transformation” is almost an “administration dose form”. It is a nested representation where the (manufactural) dose form has (adminstration) dose form.

AOB

All

Next Meeting: 11th December, 11am UTC