The Limulus amoebocyte lysate (LAL) test has replaced about 80% of the use of the rabbit pyrogen test. Ideally, human-based in vitro tests are needed, to replace the remaining use of the rabbit test and the use of the LAL test. The progress of an EU-funded project is described, in which a number of in vitro tests based on the human fever reaction are passing through a prevalidation study on the way to evaluation in a formal validation study.
HartungT., AabergeI., BertholdS., CarlinG., ChartonE., CoeckeS., FennrichS., FischerM., GommerM., HalderM., HaslovK., JahnkeM., Montag-LessingT., PooleS., SchechtmanL., WendelA., & Werner-FelmayerG. (2001). ECVAM workshop on novel pyrogen tests based on the human fever reaction. ATLA29, 99–123.
2.
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3.
BallsM., BlaauboerB.J., FentemJ.H., BrunerL., CombesR.D., EkwallB., FielderR.J., GuillouzoA., LewisR.W., LovellD.P., ReinhardtC.A., RepettoG., SladowskiD., SpielmannH., & ZuccoF. (1995). Practical aspects of the validation of toxicity test procedures. The report and recommendations of ECVAM workshop 5. ATLA23, 129–147.
4.
Cooper-HannanR., HarbellJ.W., CoeckeS., BallsM., BoweG., CervinkaM., ClothierR., HermannF., KlahmL.K., de LangeJ., LiebschM., & VanparysP. (1999). The principles of Good Laboratory Practice: application to in vitro toxicology studies. The report and recommendations of ECVAM workshop 37. ATLA27, 539–577.
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6.
FentemJ.H., ArcherG.E.B., BallsM., BothamP.A., CurrenR.D., EarlL.K., EsdaileD.J., HolzhütterH-G., & LiebschM. (1998). The ECVAM international validation study on in vitro tests for skin corrosivity. 2. Results and evaluation by the Management Team. Toxicology in Vitro12, 483–524.
7.
SpielmannH., BallsM., DupuisJ., PapeW.J.W., PechovitchG., de SilvaO., HolzhütterH-G., ClothierR., DesolleP., GerberickG.F., LiebschM., LovellW., MaurerT., PfannenbeckerU., PotthastJ.M., CsatoM., SladowskiD., SteilingW., & BrantomP. (1998). The international EU/COLIPA in vitro phototoxicity validation study: results of phase II (blind trial); part 1: the 3T3 NRU phototoxicity test. Toxicology in Vitro12, 305–327.
8.
HolzhütterH-G., ArcherG., DamiN., LovellD.P., SaltelliA., & SjostromM. (1996). Recommendations for the application of biostatistical methods during the development and validation of alternative toxicological methods. ATLA24, 511–530
9.
SchneiderB. (1999). Biometrische Methoden zur Auswertung von in-vitro-Verfahren und zur Validierung von Ersatzmethoden für Tierversuche, Hannover.Bonn, Germany: BMBF.