Triple

T22458035
Position Surface form Disambiguated ID Type / Status
Subject ICH M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals E555162 entity
Predicate relatedTo P37 FINISHED
Object ICH S7A Safety Pharmacology Studies for Human Pharmaceuticals — NE NERFINISHED

How this triple was built (3 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 S7A Safety Pharmacology Studies for Human Pharmaceuticals | Statement: [ICH M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals, relatedTo, ICH S7A Safety Pharmacology Studies for Human Pharmaceuticals]
NED1 Entity disambiguation (via context triple) gpt-5-mini-2025-08-07 
Target entity: ICH S7A Safety Pharmacology Studies for Human Pharmaceuticals
Context triple: [ICH M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals, relatedTo, ICH S7A Safety Pharmacology Studies for Human Pharmaceuticals]
  • A. ICH M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
    ICH M3(R2) is an international guideline that harmonizes requirements for nonclinical safety studies needed to support the initiation and progression of human clinical trials and the marketing authorization of pharmaceuticals.
  • B. ICH S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
    ICH S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals is an international guideline that outlines the nonclinical safety testing requirements for biotechnological products such as therapeutic proteins and monoclonal antibodies to support their clinical development and marketing authorization.
  • C. ICH S9 Nonclinical Evaluation for Anticancer Pharmaceuticals
    ICH S9 Nonclinical Evaluation for Anticancer Pharmaceuticals is an international regulatory guideline that outlines the nonclinical safety studies needed to support the development and approval of anticancer drugs in humans.
  • D. 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.
  • E. 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.
  • F. None of above. chosen
  • G. Unsure - the case is ambiguous/there is not enough information to decide.
NED2 Entity disambiguation (via description) gpt-5-mini-2025-08-07 
Target entity: ICH S7A Safety Pharmacology Studies for Human Pharmaceuticals
Target entity description: ICH S7A Safety Pharmacology Studies for Human Pharmaceuticals is an international guideline that outlines the core nonclinical safety pharmacology studies needed to evaluate the potential undesirable effects of new drugs on vital physiological functions before human use.
  • A. ICH M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
    ICH M3(R2) is an international guideline that harmonizes requirements for nonclinical safety studies needed to support the initiation and progression of human clinical trials and the marketing authorization of pharmaceuticals.
  • B. ICH S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
    ICH S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals is an international guideline that outlines the nonclinical safety testing requirements for biotechnological products such as therapeutic proteins and monoclonal antibodies to support their clinical development and marketing authorization.
  • C. ICH S9 Nonclinical Evaluation for Anticancer Pharmaceuticals
    ICH S9 Nonclinical Evaluation for Anticancer Pharmaceuticals is an international regulatory guideline that outlines the nonclinical safety studies needed to support the development and approval of anticancer drugs in humans.
  • D. 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.
  • E. 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.
  • F. None of above. chosen

Provenance (2 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_69e11e51fdec8190adfdf9f8a6362221 completed April 16, 2026, 5:37 p.m.
NER Named-entity recognition batch_69f15b7d00208190955a70e2c22d25a4 completed April 29, 2026, 1:14 a.m.
Created at: April 16, 2026, 8:48 p.m.