The validation and acceptance of alternatives to animal testing

Toxicology in Vitro : an International Journal Published in Association with BIBRA
M Balls, J H Fentem

Abstract

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?

References

Aug 1, 1996·Toxicology in Vitro : an International Journal Published in Association with BIBRA·L H BrunerR D Curren
Feb 1, 1997·Toxicology in Vitro : an International Journal Published in Association with BIBRA·P G BrantomM Stern
Jun 1, 1998·Toxicology in Vitro : an International Journal Published in Association with BIBRA·H SpielmannP Brantom
Aug 1, 1998·Toxicology in Vitro : an International Journal Published in Association with BIBRA·J H FentemM Liebsch
Aug 1, 1994·Toxicology in Vitro : an International Journal Published in Association with BIBRA·E WalumB Ekwall

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Citations

May 1, 2001·The Science of the Total Environment·M Balls, E Sabbioni
Aug 1, 1998·Toxicology in Vitro : an International Journal Published in Association with BIBRA·J H FentemM Liebsch
Aug 13, 2011·SAR and QSAR in Environmental Research·M HewittT W Schultz
Apr 18, 2012·SAR and QSAR in Environmental Research·K R PrzybylakM Hewitt
Jan 19, 2016·Toxicology in Vitro : an International Journal Published in Association with BIBRA·A HessK Sewald
May 17, 2005·Toxicology in Vitro : an International Journal Published in Association with BIBRA·Argelia Castaño, María José Gómez-Lechón
Jan 18, 2018·Journal of Food Science·Yiming FengSoo-Yeun Lee
Oct 22, 2002·ILAR Journal·Michael Balls
Jan 7, 2003·Alternatives to Laboratory Animals : ATLA·Andrew P Worth, Michael Balls
Dec 23, 2004·Alternatives to Laboratory Animals : ATLA·Robert D Combes, Michael Balls
Jun 1, 2004·Alternatives to Laboratory Animals : ATLA·Andrew P Worth, Michael Balls
Dec 15, 2004·Alternatives to Laboratory Animals : ATLA·Lutz Edler, Carina Ittrich
Jan 7, 2003·Alternatives to Laboratory Animals : ATLA·Ludwig A Hothorn
Mar 23, 2001·Alternatives to Laboratory Animals : ATLA·A P Worth, M Balls
Apr 21, 2001·Journal of Agricultural and Food Chemistry·G PuyfoulhouxB Caporiccio

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