The Validation and Acceptance of Alternatives to Animal Testing

Knowledge Source Identification
Knowledge source name The Validation and Acceptance of Alternatives to Animal Testing
Owner/Developer Toxicology in Vitro
Country Netherlands
Languages English
Description Validation is the key to the regulatory status of alternative methods. A series of questions are put, to which answers are given, including the following: What is validation? What is meant by “relevance”, “reliability” and “purpose”? Why and when is formal validation necessary? What comes before and after a formal validation study? How have validation criteria been defined, and to what extent have they been harmonized internationally? How are validation studies set up, managed and funded? What is a test? Do prediction models have to be validated? What is prevalidation? What is acceptance, and who is responsible for acceptance? How are validation studies reported? How should a validated test be defined and recognized? Must all new tests be validated? Are the same standards being applied to new in vitro and new in vivo tests? Has validation been successful so far? What can be done to improve validation? Is validation helping or hindering the development of in vitro toxicology and the implementation of the ‘Three Rs’ of Russell & Burch?
Knowledge Source Category
Category Publication
Sub categories Review / Research article
Knowledge Dissemination and Sharing
Dissemination channel Website, Printed
Targeted audience (specified/objective analysis) Not specified
Users access User registration, Fee-based access
Knowledge Characterization
3Rs relevance Replacement, Reduction, Refinement
Purpose Validation, Regulatory testing, Documentation and information
Technology/Tools Alternative test methods (in vitro), Non-testing methods (in silico), Animal testing (in vivo)