ICH Q1 Stability Testing of New Drug Substances and Products

All labels observed (8)

Label	Occurrences
ICH Q1 Stability Testing of New Drug Substances and Products canonical	1
ICH Q1A(R2)	1
ICH Q1A(R2): Stability Testing of New Drug Substances and Products	1
ICH Q1B: Photostability Testing of New Drug Substances and Products	1
ICH Q1C: Stability Testing for New Dosage Forms	1
ICH Q1D: Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products	1
ICH Q1E: Evaluation of Stability Data	1
ICH Q1F: Stability Data Package for Registration Applications in Climatic Zones III and IV	1

How this entity was disambiguated

This entity first appeared as the object of triple T5932232 — 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 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.

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

Statements (48)

Predicate	Object
instanceOf	ICH guideline ⓘ pharmaceutical stability guideline ⓘ regulatory guideline ⓘ
abbreviatedAs	ICH Q1 ⓘ
aimsTo	ensure quality of pharmaceutical products over shelf life ⓘ harmonise stability testing requirements among ICH regions ⓘ support assignment of expiration dates for drug products ⓘ support assignment of retest periods for drug substances ⓘ
appliesIn	European Union ⓘ Japan ⓘ United States ⓘ linked to: United States of America
appliesTo	marketed pharmaceutical products with significant changes ⓘ new chemical entities ⓘ new drug products ⓘ
covers	evaluation and extrapolation of stability data ⓘ relative humidity conditions for stability studies ⓘ requirements for stability testing after packaging changes ⓘ temperature conditions for stability studies ⓘ
defines	requirements for accelerated stability studies ⓘ requirements for intermediate stability studies ⓘ requirements for long-term stability studies ⓘ requirements for shelf life estimation ⓘ requirements for stability study design ⓘ requirements for stability testing of drug products in proposed container-closure systems ⓘ requirements for stability-indicating analytical methods ⓘ requirements for storage condition assignment ⓘ requirements for stress testing of drug substances ⓘ requirements for testing frequency in stability studies ⓘ
hasPart	ICH Q1A(R2) ⓘ linked to: ICH Q1 Stability Testing of New Drug Substances and Products ICH Q1B ⓘ ICH Q1C ⓘ ICH Q1D ⓘ ICH Q1E ⓘ linked to: ICH Q1 ICH Q1F ⓘ linked to: ICH Q1
issuedBy	International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ⓘ
language	English ⓘ
regulates	stability testing of new drug products ⓘ stability testing of new drug substances ⓘ
relatedTo	Good Manufacturing Practice ⓘ linked to: Good Manufacturing Practices pharmaceutical quality by design ⓘ
subjectOf	ICH Q1A(R2): Stability Testing of New Drug Substances and Products ⓘ linked to: ICH Q1 Stability Testing of New Drug Substances and Products ICH Q1B: Photostability Testing of New Drug Substances and Products ⓘ linked to: ICH Q1 Stability Testing of New Drug Substances and Products ICH Q1C: Stability Testing for New Dosage Forms ⓘ linked to: ICH Q1 Stability Testing of New Drug Substances and Products ICH Q1D: Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products ⓘ linked to: ICH Q1 Stability Testing of New Drug Substances and Products ICH Q1E: Evaluation of Stability Data ⓘ linked to: ICH Q1 Stability Testing of New Drug Substances and Products ICH Q1F: Stability Data Package for Registration Applications in Climatic Zones III and IV ⓘ linked to: ICH Q1 Stability Testing of New Drug Substances and Products
usedBy	pharmaceutical companies ⓘ regulatory authorities in ICH regions ⓘ

How these facts were elicited