Points of Reference in the Validation Process

OECD (2005). Guidance Document on the Validation and International Acceptance of New or Updated Test Methods for Hazard Assessment. OECD Series on Testing and Assessment No. 34, ENV/JM/MONO (2005) 14, 96pp. Paris, France: OECD. Available at: http://appli1.oecd.org/olis/2005doc.nsf/linkto/env-jmmono (2005)14 (Accessed 11.06.08).

Balls M. , Blaauboer B. , Brusick D. , Frazier J. , Lamb D. , Pemberton M. , Reinhardt C. , Roberfroid M. , Rosenkranz H. , Schmid B. , Spielmann H. , Stammati A.L. & Walum E. (1990). Report and recommendations of the CAAT/ERGATT workshop on validation of toxicity test procedures. ATLA 18, 303–337.

Balls M. , Blaauboer B. , Fentem J.H. , Bruner L. , Combes R.D. , Ekwall B. , Fielder R.J. , Guillouzo A. , Lewis R.W. , Lovell D.P. , Repetto G. , Sladowski D. , Spielmann H. & Zucco F. (1995). Practical aspects of the validation of toxicity test procedures. The report and recommendations of ECVAM workshop 5. ATLA 23, 129–147.

Liebsch M. & Spielmann H. (2002). Currently available in vitro methods used in the regulatory toxicology. Toxicology Letters 127, 127–134.

Hoffmann S. , Cole T. & Hartung T. (2005). Skin irritation: prevalence, variability and regulatory classification of existing in vivo data from industrial chemicals. Regulatory Toxicology & Pharmacology 41, 159–166.

Hoffman R.S. (2007). Understanding the limitations of retrospective analyses of poison center data. Clinical Toxicology 45, 943–945.

Barratt M.D. , Brantom P.G. , Fentem J.H. , Gerner I. , Walker A.P. & Worth A.P. (1998). The ECVAM international study on in vitro test for skin corrosivity. 1. Selection and distribution of the test chemicals. Toxicology in Vitro 12, 471–482.

Eskes C. , Cole T. , Hoffmann S. , Worth A. , Cockshot A. , Gerner I. & Zuang V. (2007). ECVAM international validation study on in vitro tests for acute skin irritation: selection of test chemicals. ATLA 35, 603–619.

International Organization for Standardization (2007). International Vocabulary of Metrology — Basic and General Concepts and Associated Terms (VIM). ISO/IEC Guide 99:2007, 92pp. Geneva, Switzerland: ISO.

Balls M. (1997). Defined structural and performance criteria would facilitate the validation and acceptance of alternative test procedures. ATLA 25, 483–484.

Hartung T. , Bremer S. , Casati S. , Coecke S. , Corvi R. , Fortaner S. , Gribaldo L. , Halder M. , Hoffmann S. , Janusch-Roi A. , Prieto P. , Sabbioni E. , Scott L. , Worth A. & Zuang V. (2004). A modular approach to the ECVAM principles on test validity. ATLA 32, 467–472.

ICCVAM/NICEATM (2004). Recommended Performance Standards for In Vitro Test Methods for Skin Corrosion, 100pp. Research Triangle Park, NC, USA: National Toxicology Program. Available at: http://iccvam.niehs.nih.gov/methods/dermal/epiderm/ps/ps044510.htm (Accessed 11.06.08).

OECD (2004). OECD Guideline for Testing of Chemicals No. 430: In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test, 12pp. Paris, France: OECD.

OECD (2004). OECD Guideline for Testing of Chemicals No. 431: In Vitro Skin Corrosion: Human Skin Model Test, 8pp. Paris, France: OECD.

OECD (2007). Guidance on Grouping of Chemicals. OECD Series on Testing and Assessment No. 80, ENV/JM/MONO(2007)28, 99pp. Paris, France: OECD. Available at: http://www.oecd.org/dataoecd/53/62/39850072.pdf (Accessed 11.06.08).

Balls M. , Amcoff P. , Bremer S. , Casati S. , Coecke S. , Clothier R. , Combes R. , Corvi R. , Curren R. , Eskes C. , Fentem J. , Gribaldo L. , Halder M. , Hartung T. , Hoffmann S. , Schechtman L. , Scott L. , Spielmann H. , Stokes W. , Tice R. , Wagner D. & Zuang V. (2006). The principles of weight of evidence validation of test methods and testing strategies. The report and recommendations of ECVAM workshop 58. ATLA 34, 603–620.

OECD (1998). OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring. Paris, France: OECD. Available at: http://www.oecd.org/document/63/0,2340,en_2649_34381_2346175_1_1_1_1,00.html (Accessed 11.06.08).

Hothorn L.A. (2002). Selected biostatistical aspects of the validation of in vitro toxicological assays. ATLA 30, Suppl. 2, 93–98.

Hui S.L. & Walter S.D. (1980). Estimating the error rates of diagnostic tests. Biometrics 36, 167–171.

Hoffmann S. & Hartung T. (2005). Diagnosis: toxic! — Trying to apply approaches of clinical diagnostics and prevalence in toxicology considerations. Toxicological Sciences 85, 422–428.

World Organisation for Animal Health (2007). Manual for Diagnostic Tests and Vaccines for Terrestrial Animals. Chapter 1.1.3: Principles of Validation of Diagnostic Assays for Infectious Diseases, 14pp. Paris, France: OiE. Available at: http://www.oie.int/eng/normes/mmanual/A_00013.htm (Accessed 11.06.08).

Joseph L. , Gyorkos T.W. & Coupal L. (1995). Bayesian estimation of disease prevalence and the parameters of diagnostic tests in the absence of a gold standard. American Journal of Epidemiology 141, 263–272.

Pepe M.S. (2003). The Statistical Evaluation of Medical Tests for Classification and Prediction. Oxford Statistical Science Series No. 28, 320pp. New York, NY, USA: Oxford University Press.

Prinsen M.K. (2006). The Draize eye test and in vitro alternatives; a left-handed marriage? Toxicology in Vitro 20, 78–81.