Prolonged-release transdermal patch

Prolonged-release transdermal patch clinical drug concepts modeled previously using concentration strength normalized to per 1 hour will use presentation strength based on the labeled total amount delivered over time (e.g., /16, /24 [usual manufacturer-documented period], /72 hours), in alignment with product SPCs and international editorial policy.

Opioid patches (e.g., fentanyl, buprenorphine) are an exception and must retain the /1 hour expression, consistent with manufacturer documentation and regulatory standards. This reflects patient safety requirements for these strong, controlled substances. These concepts must also be modeled using presentation strength.

• Presentation strength is to be used for all prolonged-release transdermal patch concepts.

• The |Has unit of presentation (attribute)| with a value of |Patch (unit of presentation)| is added to all prolonged-release transdermal patch concepts.

Units will reflect the duration, strength, and units as specified in the SPC.