Triple

T22458076
Position Surface form Disambiguated ID Type / Status
Subject ICH S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals E555163 entity
Predicate relatedTo P37 FINISHED
Object ICH M3 Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization — NE NERFINISHED

How this triple was built (2 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 M3 Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization | Statement: [ICH S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals, relatedTo, ICH M3 Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization]
NED1 Entity disambiguation (via context triple) gpt-5-mini-2025-08-07 
Target entity: ICH M3 Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization
Context triple: [ICH S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals, relatedTo, ICH M3 Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization]
  • A. ICH M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals chosen
    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 E8 General Considerations for Clinical Trials
    ICH E8 General Considerations for Clinical Trials is an international guideline that outlines fundamental principles and quality considerations for the design, conduct, and evaluation of clinical studies across all phases of drug development.
  • E. Pharmacovigilance Risk Assessment Committee within the European Medicines Agency
    The Pharmacovigilance Risk Assessment Committee within the European Medicines Agency is an expert body responsible for evaluating and monitoring the safety of medicines across the European Union and providing recommendations on managing and communicating medicine-related risks.
  • F. None of above.
  • G. Unsure - the case is ambiguous/there is not enough information to decide.

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.