Triple
T5932232
| Position | Surface form | Disambiguated ID | Type / Status |
|---|---|---|---|
| Subject | ICH |
E131963
|
entity |
| Predicate | notableGuideline |
P66981
|
FINISHED |
| Object |
ICH Q1 Stability Testing of New Drug Substances and Products
ICH Q1 Stability Testing of New Drug Substances and Products is an international regulatory guideline that defines the scientific principles and study requirements for assessing the stability, shelf life, and storage conditions of new pharmaceutical substances and finished products.
|
E555140
|
NE FINISHED |
How this triple was built (5 steps)
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.
NER
Named-entity recognition
gpt-5-mini
Instruction
Given a phrase, classify it is english named entity (e.g., persons, organizations, works of art) in Latin script, or not (e.g., literals, dates, URLs, verbose phrases). For disambiguation, the statement where the phrase occurs as object is also given. Please return a JSON object with `phrase` (string, the phrase being analyzed) and `is_ne` (boolean, indicating whether the phrase is a Named Entity).
Input
Phrase: ICH Q1 Stability Testing of New Drug Substances and Products | Statement: [ICH, notableGuideline, ICH Q1 Stability Testing of New Drug Substances and Products]
NED1
Entity disambiguation (via context triple)
gpt-5-mini-2025-08-07
Target entity: ICH Q1 Stability Testing of New Drug Substances and Products Context triple: [ICH, notableGuideline, ICH Q1 Stability Testing of New Drug Substances and Products]
-
A.
ICH Q8 Pharmaceutical Development
ICH Q8 Pharmaceutical Development is an international guideline that outlines a systematic, science- and risk-based approach to pharmaceutical product and process development, forming a core part of the ICH quality framework.
-
B.
ICH Q10 Pharmaceutical Quality System
ICH Q10 Pharmaceutical Quality System is an international guideline that establishes a comprehensive, lifecycle-based framework for pharmaceutical quality management to ensure consistent product quality and regulatory compliance.
-
C.
Certificates of Suitability to the monographs of the European Pharmacopoeia
Certificates of Suitability to the monographs of the European Pharmacopoeia are official documents issued by the European Directorate for the Quality of Medicines & HealthCare (EDQM) confirming that a substance’s quality complies with the relevant European Pharmacopoeia monograph, thereby simplifying regulatory approval for medicines across Europe.
-
D.
Office of Pharmaceutical Quality
The Office of Pharmaceutical Quality is a U.S. Food and Drug Administration office responsible for ensuring the quality, safety, and consistency of human drugs throughout their lifecycle.
-
E.
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a global body that develops and promotes unified scientific and technical standards to ensure the safety, quality, and efficacy of medicines worldwide.
- F. None of above. chosen
- G. Unsure - the case is ambiguous/there is not enough information to decide.
NEDg
Description generation
gpt-5.1
Instruction
Generate a one-sentence description of the target entity. You are given a context triple in the form (subject, predicate, object), where the object is the target entity. # Instructions Use the triple to infer relevant information about the entity. Describe the entity based on what is most defining, well-known. Avoid repeating the information from the triple, unless really essential. # Response Format Return only the sentence: "Description: [one-sentence description of the target entity]"
Input
Entity: ICH Q1 Stability Testing of New Drug Substances and Products Triple: [ICH, notableGuideline, ICH Q1 Stability Testing of New Drug Substances and Products]
Generated description
ICH Q1 Stability Testing of New Drug Substances and Products is an international regulatory guideline that defines the scientific principles and study requirements for assessing the stability, shelf life, and storage conditions of new pharmaceutical substances and finished products.
NED2
Entity disambiguation (via description)
gpt-5-mini-2025-08-07
Target entity: ICH Q1 Stability Testing of New Drug Substances and Products Target entity description: ICH Q1 Stability Testing of New Drug Substances and Products is an international regulatory guideline that defines the scientific principles and study requirements for assessing the stability, shelf life, and storage conditions of new pharmaceutical substances and finished products.
-
A.
ICH Q8 Pharmaceutical Development
ICH Q8 Pharmaceutical Development is an international guideline that outlines a systematic, science- and risk-based approach to pharmaceutical product and process development, forming a core part of the ICH quality framework.
-
B.
ICH Q10 Pharmaceutical Quality System
ICH Q10 Pharmaceutical Quality System is an international guideline that establishes a comprehensive, lifecycle-based framework for pharmaceutical quality management to ensure consistent product quality and regulatory compliance.
-
C.
Certificates of Suitability to the monographs of the European Pharmacopoeia
Certificates of Suitability to the monographs of the European Pharmacopoeia are official documents issued by the European Directorate for the Quality of Medicines & HealthCare (EDQM) confirming that a substance’s quality complies with the relevant European Pharmacopoeia monograph, thereby simplifying regulatory approval for medicines across Europe.
-
D.
Office of Pharmaceutical Quality
The Office of Pharmaceutical Quality is a U.S. Food and Drug Administration office responsible for ensuring the quality, safety, and consistency of human drugs throughout their lifecycle.
-
E.
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a global body that develops and promotes unified scientific and technical standards to ensure the safety, quality, and efficacy of medicines worldwide.
- F. None of above. chosen
PD
Predicate disambiguation
gpt-5-mini-2025-08-07
Target predicate: notableGuideline Context triple: [ICH, notableGuideline, ICH Q1 Stability Testing of New Drug Substances and Products]
-
A.
notableStandard
Indicates that one entity is a widely recognized or influential standard that the other entity is associated with or exemplifies.
-
B.
notableRule
Indicates that a rule or regulation is particularly significant, prominent, or noteworthy within a given context.
-
C.
notableCriterion
Indicates that something is distinguished or recognized based on a particular standard, measure, or qualifying condition.
-
D.
notableProvision
Indicates that one entity is a significant or noteworthy clause, term, or condition contained within another entity, such as a document, agreement, or law.
-
E.
notableSafety
Indicates that an entity is recognized for having significant safety characteristics, performance, or impact relative to others.
- F. None of above. chosen
Provenance (7 batches)
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_69c0085b75e88190a632f9691f9da48b |
completed | March 22, 2026, 3:18 p.m. |
| NER | Named-entity recognition | batch_69c03f26f51881908cc253fe5775a1fc |
completed | March 22, 2026, 7:12 p.m. |
| NED1 | Entity disambiguation (via context triple) | batch_69c0c064d2a4819096085668182cfde1 |
completed | March 23, 2026, 4:24 a.m. |
| NEDg | Description generation | batch_69c0c109b3288190928dc4539a2872c2 |
completed | March 23, 2026, 4:26 a.m. |
| NED2 | Entity disambiguation (via description) | batch_69c0c1f6fe60819080a00976740b6a9c |
completed | March 23, 2026, 4:30 a.m. |
| PD | Predicate disambiguation | batch_69c03355caf08190b960563a1aed23f9 |
completed | March 22, 2026, 6:22 p.m. |
| PDg | Predicate description generation | batch_69c03f23dd20819089dbf0de0d913602 |
completed | March 22, 2026, 7:12 p.m. |
Created at: March 22, 2026, 4 p.m.