ICH S9 Nonclinical Evaluation for Anticancer Pharmaceuticals
E131972
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.
All labels observed (2)
| Label | Occurrences |
|---|---|
| ICH S9 Nonclinical Evaluation for Anticancer Pharmaceuticals canonical | 2 |
| ICH S9 | 1 |
How this entity was disambiguated
This entity first appeared as the object of triple T1151211 — resolving that mention is where its identity was fixed. The disambiguator weighed these candidate entities and picked the highlighted one (or “None”, minting a new entity). This is how homonymy is resolved: the same surface form can point to different entities.
NED1
Entity disambiguation (via context triple)
gpt-5-mini-2025-08-07
Target entity: ICH S9 Nonclinical Evaluation for Anticancer Pharmaceuticals Context triple: [International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, notableWork, ICH S9 Nonclinical Evaluation for Anticancer Pharmaceuticals]
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A.
Molecular Cancer Therapeutics
Molecular Cancer Therapeutics is a peer-reviewed scientific journal focusing on the discovery, development, and clinical evaluation of novel cancer therapeutics.
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B.
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.
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C.
Cancer Res
Cancer Res is a leading peer-reviewed scientific journal that publishes research on the molecular and cellular biology, genetics, and treatment of cancer.
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D.
NCI-Designated Cancer Centers Program
The NCI-Designated Cancer Centers Program is a U.S. network of leading academic and research institutions recognized for excellence in cancer research, treatment, and prevention.
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E.
National Institutes of Health intramural research program
The National Institutes of Health intramural research program is a large, government-funded biomedical research enterprise in which NIH scientists conduct basic, translational, and clinical studies within NIH facilities.
- 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 S9 Nonclinical Evaluation for Anticancer Pharmaceuticals Target entity description: 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.
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A.
Molecular Cancer Therapeutics
Molecular Cancer Therapeutics is a peer-reviewed scientific journal focusing on the discovery, development, and clinical evaluation of novel cancer therapeutics.
-
B.
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.
-
C.
Cancer Res
Cancer Res is a leading peer-reviewed scientific journal that publishes research on the molecular and cellular biology, genetics, and treatment of cancer.
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D.
NCI-Designated Cancer Centers Program
The NCI-Designated Cancer Centers Program is a U.S. network of leading academic and research institutions recognized for excellence in cancer research, treatment, and prevention.
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E.
National Institutes of Health intramural research program
The National Institutes of Health intramural research program is a large, government-funded biomedical research enterprise in which NIH scientists conduct basic, translational, and clinical studies within NIH facilities.
- F. None of above. chosen
Statements (48)
| Predicate | Object |
|---|---|
| instanceOf |
ICH guideline
ⓘ
nonclinical safety guideline ⓘ regulatory guideline ⓘ |
| abbreviation | ICH ⓘ |
| addresses |
carcinogenicity assessment for anticancer drugs
ⓘ
dose selection for nonclinical studies ⓘ duration of nonclinical toxicity studies ⓘ genotoxicity testing for anticancer drugs ⓘ nonclinical evaluation of supportive care agents used with anticancer drugs ⓘ nonclinical support for combination anticancer regimens ⓘ reproductive toxicity considerations for anticancer drugs ⓘ risk–benefit considerations specific to oncology indications ⓘ safety pharmacology considerations for anticancer drugs ⓘ species selection for nonclinical studies ⓘ timing of nonclinical studies relative to clinical trials ⓘ toxicology study design for anticancer drugs ⓘ use of nonclinical data to support first-in-human trials in cancer patients ⓘ |
| appliesTo |
biotechnology-derived anticancer products
ⓘ
cytotoxic anticancer drugs ⓘ molecularly targeted anticancer drugs ⓘ small-molecule anticancer drugs ⓘ |
| developedBy | International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ⓘ |
| distinguishesFrom | non-oncology pharmaceutical guidelines ⓘ |
| documentType | scientific guideline ⓘ |
| focusesOn |
anticancer pharmaceuticals
ⓘ
nonclinical safety evaluation ⓘ |
| harmonizes | nonclinical requirements across ICH regions for anticancer drugs ⓘ |
| intendedPopulation |
adult cancer patients
ⓘ
pediatric cancer patients ⓘ |
| primaryPurpose |
to outline nonclinical safety studies needed to support development of anticancer drugs in humans
ⓘ
to support marketing authorization of anticancer pharmaceuticals ⓘ |
| regionOfApplication |
European Union
ⓘ
Japan ⓘ United States ⓘ
linked to:
United States of America
|
| regulatoryDomain | human anticancer pharmaceuticals ⓘ |
| regulatoryUse |
clinical trial authorization
ⓘ
drug development ⓘ marketing authorization applications ⓘ |
| relatedTo |
ICH M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
ⓘ
ICH S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals ⓘ |
| scope |
nonclinical data requirements for registration of anticancer pharmaceuticals
ⓘ
nonclinical safety studies to support all stages of clinical development of anticancer drugs ⓘ |
| shortName | ICH S9 ⓘ |
| subjectOf | nonclinical evaluation of anticancer pharmaceuticals ⓘ |
| title | ICH S9 Nonclinical Evaluation for Anticancer Pharmaceuticals ⓘ |
| usedBy |
oncology drug developers
ⓘ
pharmaceutical companies ⓘ regulatory authorities ⓘ |
How these facts were elicited
The pipeline generated the facts above by prompting gpt-5.1 with this entity's name + description and the instruction below.
Instruction
You are a knowledge base construction expert. Given a subject entity and a description of it, return factual statements that you know for the subject as a JSON list of dictionaries(triples), where keys must be "subject", "predicate" and "object". The number of facts may be very high, between 25 to 50 or more, for very popular subjects. For less popular subjects, the number of facts can be very low, like 5 or 10. # Requirements - If you don't know the subject at all, return an empty list. - If the subject is not a named entity, return an empty list. - Include at least one triple where predicate is "instanceOf". - Do not get too wordy. - Separate several objects into multiple triples with one object.
Input
Subject: ICH S9 Nonclinical Evaluation for Anticancer Pharmaceuticals Description of subject: 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.
Referenced by (3)
Full triples — surface form annotated when it differs from this entity's canonical label.
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
→
notableWork
→
ICH S9 Nonclinical Evaluation for Anticancer Pharmaceuticals
ⓘ
ICH S9 Nonclinical Evaluation for Anticancer Pharmaceuticals
→
title
→
ICH S9 Nonclinical Evaluation for Anticancer Pharmaceuticals
ⓘ
linked to: ICH S9 Nonclinical Evaluation for Anticancer Pharmaceuticals