Triple
T25614566
| Position | Surface form | Disambiguated ID | Type / Status |
|---|---|---|---|
| Subject | Paragraph I certification |
E642123
|
entity |
| Predicate | instanceOf |
P0
|
FINISHED |
| Object | U.S. generic drug regulatory concept |
C46327
|
CONCEPT FINISHED |
How this triple was built (1 step)
Every LLM step that produced this triple, in pipeline order — named-entity classification, the disambiguation choices (the exact options shown, with the pick highlighted), and the generated description. The batch + timestamp of each is in the Provenance table below.
CD
Concept disambiguation
gpt-5-mini-2025-08-07
Target class: U.S. generic drug regulatory concept Context triple: [Paragraph I certification, instanceOf, U.S. generic drug regulatory concept]
-
A.
pharmaceutical regulatory guideline
chosen
A pharmaceutical regulatory guideline is an authoritative document that defines the standards, requirements, and procedures that pharmaceutical products must meet to be developed, tested, approved, manufactured, and monitored to ensure their quality, safety, and efficacy.
-
B.
generic drug manufacturer
A generic drug manufacturer is a pharmaceutical company that produces bioequivalent, non-branded versions of patented or previously patented medications once exclusivity has expired, typically at lower cost.
-
C.
pharmacy regulator
A pharmacy regulator is an authority or organization responsible for overseeing, licensing, and enforcing standards for pharmacies and pharmacists to ensure the safe, ethical, and effective use of medications.
-
D.
organ of the International Council for Harmonisation
An organ of the International Council for Harmonisation is a formal body or component within the ICH structure that is responsible for developing, coordinating, or overseeing international guidelines and activities related to the harmonisation of pharmaceutical regulation.
-
E.
reversal agent for factor Xa inhibitors
A reversal agent for factor Xa inhibitors is a therapeutic substance designed to rapidly neutralize the anticoagulant effects of factor Xa–inhibiting drugs in situations such as life-threatening bleeding or urgent surgery.
- F. None of above.
Provenance (1 batch)
The batch behind each pipeline step, in order, with when it ran. Timestamps are batch-level — stages were processed in waves, so the object chain (NER → NED1 → NEDg → NED2) reads in order, but predicate / elicitation batches can sit in a different wave.
| Step | Stage | Batch ID | Status | When |
|---|---|---|---|---|
| creating | Elicitation | batch_69e77e7a96748190b10f2699041e4e43 |
completed | April 21, 2026, 1:41 p.m. |
Created at: April 21, 2026, 4:58 p.m.