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|Title:||3Rs approaches in pharmacology and toxicology|
|Authors:||MADIA FEDERICA; PRICE Anna|
|Publisher:||Pàtron editore S.r.l.|
|Type:||Articles in periodicals and books|
|Abstract:||Over the last decades, the use of laboratory animals for scientific purposes has encountered serious objections. Strong actions have been taken from the scientific arena as well as from a direct involvement to the 'Animal Welfare Debate' of Citizens. Concerns have risen exponentially, such that Regulatory Authorities had to reconsider the way of using animals within the scientific field. Since the first publication by Russell and Burch in 1959, the 3Rs fundamental principles of Replacement, Reduction and Refinement for driving ethical research, testing and education using animals, have been widely accepted and adapted to science research. The principles are currently incorporated as a key concept for humane use of animals in research into various important legislations. However, the development and validation of alternative methods and approaches are still on-going complex and lengthy processes. The chapter is aimed at giving a broad introduction to the options and activities in place to the implementation of 3Rs in different areas: safety pharmacology, quality control of medicines and regulatory toxicology. The principles of validation internationally recognized and the validation approach developed at European level are also described.|
|JRC Directorate:||Institute for Health and Consumer Protection Historical Collection|
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