Chapter 2: The Principles and Procedures of Validation

Balls M. , & Fentem J.H. (1999). The validation and acceptance of alternatives to animal testing. Toxicology in Vitro 13, 837–846.

Russell W.M.S. , & Burch R.L. (1959). The Principles of Humane Experimental Technique, 238 pp. London, UK: Methuen.

Archer G. , Balls M. , Bruner L.H. , Curren R.D. , Fentem J.H. , Holzhütter H-G. , Liebsch M. , Lovell D.P. , & Southee J.A. (1997). The validation of toxicological prediction models. ATLA 25, 505–516.

Bruner L.H. , Carr G.J. , Chamberlain M. , & Curren R.D. (1996). Validation of alternative methods for toxicity testing. Toxicology in Vitro 10, 479–501.

Bruner L. , Carr G. , Chamberlain M. , & Curren R. (1996). No prediction model — no validation study. ATLA 24, 211–217.

Archer G. (1996). No statistics, no science — let alone validation studies. ATLA 24, 453–456.

Holzhütter H-G. , & Spielmann H. (1996). The use of prediction models in toxicology: what should they predict? ATLA 24, 881–884.

Worth A.P. , & Balls M. (2001). The importance of the prediction model in the development and validation of alternative tests. ATLA 29, 135–143.

Balls M. , Blaauboer B. , Brusick D. , Frazier J. , Lamb D. , Pemberton M. , Reinhardt C. , Rober-froid M. , Rosenkranz H. , Schmid B. , Spielmann H. , Stammati A-L. , & Walum E. (1990). Report and recommendations of the CAAT/ERGATT workshop on the validation of toxicity test procedures. ATLA 18, 313–337.

Balls M. , Blaauboer B.J. , Fentem J.H. , Bruner L. , Combes R.D. , Ekwall B. , Fielder R.J. , Guillouzo A. , Lewis R.W. , Lovell D.P. , Reinhardt C.A. , 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.

Fentem J.H. , & Balls M. (1997). The ECVAM approach to validation. In Developments in Animal and Veterinary Sciences, Volume 27, Animal Alternatives, Welfare and Ethics. Proceedings of the 2nd World Congress on Alternatives and Animal Use in the Life Sciences, Utrecht, The Netherlands, 20–24 October 1996 (ed. van Zutphen L.F.M. , & Balls M. ), pp. 1083–1089. Amsterdam, The Netherlands: Elsevier.

Worth A.P. , & Balls M. (2001). The role of ECVAM in promoting the regulatory acceptance of alternative methods in the European Union. ATLA 29, 525–535.

Curren R.D. , Southee J.A. , Spielmann H. , Liebsch M. , Fentem J.H. , & Balls M. (1995). The role of prevalidation in the development, validation and acceptance of alternative methods. ATLA 23, 211–217.

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

Liebsch M. , Traue D. , Barrabas C. , Spielmann H. , Uphill P. , Wilkins S. , McPherson J.P. , Wiemann C. , Kaufmann , Remmele M. , & Holzhütter H-G. (2000). The ECVAM prevalidation study on the use of EpiDerm for skin corrosivity testing. ATLA 28, 371–401.

Fentem J.H. , Archer G.E.B. , Balls M. , Botham P.A. , Curren R.D. , Earl L.K. , Esdaile D.J. , Holzhütter H.G. , & Liebsch M. (1998). The ECVAM international validation study on in vitro tests for skin corrosivity. II. Results and evaluation by the management team. Toxicology in Vitro 12, 483–524.

Balls M. , & Karcher W. (1995). The validation of alternative test methods. ATLA 23, 884–886.

Balls M. , & Fentem J.H. (1997). Progress toward the validation of alternative tests. ATLA 25, 33–43.

NIH (1997). Validation and Regulatory Acceptance of Toxicological Test Methods. A Report of the Ad Hoc Interagency Coordinating Committee on the Validation of Alternative Methods. NIH Publication 97–3981, 105 pp. Research Triangle Park, NC, USA: NIEHS.

NIH (1999). Evaluation of the Validation Status of Toxicological Methods: General Guidelines for Submissions to ICCVAM (Revised, October 1999). NIH Publication 99–4496, 44 pp. Research Triangle Park, NC, USA: NIEHS.

OECD (1996). Final Report of the OECD Workshop on Harmonization of Validation and Acceptance Criteria for Alternative Toxicological Test Methods, 60 pp. Paris, France: OECD.

Cooper-Hannan R. , Harbell J.W. , Coecke S. , Balls M. , Bowe G. , Cervinka M. , Clothier R. , Hermann F. , Klahm L.K. , de Lange J. , Liebsch M. , & Vanparys P. (1999). The principles of Good Laboratory Practice: application to in vitro toxicology studies. The report and recommendations of ECVAM workshop 37. ATLA 27, 539–577.

Holzhütter H-G. , Archer G. , Dami N. , Lovell D.P. , Saltelli A. , & Sjöström M. (1996). Recommendations for the application of biostatistical methods during the development and validation of alternative toxicological methods. ECVAM biostatistics task force report 1. ATLA 24, 511–530.

Spielmann H. , Liebsch M. , Kalweit S. , Moldenhauer F. , Wirnsberger T. , Holzhütter H-G. , Schneider B. , Glaser S. , Gerner I. , Pape W.J.W. , Kreiling R. , Krauser K. , Miltenburger H.G. , Steiling W. , Luepke N.P. , Muller N. , Kreuzer H. , Murmann P. , Spengler J. , Bertram-Neis E. , Siegemund B. , & Wiebel F.J. (1996). Results of a validation study in Germany on two in vitro alternatives to the Draize eye irritation test, the HET-CAM test and the 3T3-NRU cytotoxicity test. ATLA 24, 741–858.

Genschow E. , Scholz G. , Brown N.A. , Piersma A.H. , Brady M. , Clemann N. , Huuskonen H. , Paillard F. , Bremer S. , & Spielmann H. (2000). Development of prediction models for three in vitro embryotoxicity tests in an ECVAM validation study. In Vitro and Molecular Toxicology 13, 51–65.

Worth A.P. , & Cronin M.T.D. (2001). Prediction models for eye irritation potential based on endpoints of the HET-CAM and neutral red assays. In Vitro and Molecular Toxicology 14, 143–156.

Balls M. , Botham P.A. , Bruner L.H. , & Spielmann H. (1995). The EC/HO international validation study on alternatives to the Draize eye irritation test. Toxicology in Vitro 9, 871–929.

Botham P.A. , Chamberlain M. , Barratt M.D. , Curren R.D. , Esdaile D.J. , Gardner J.R. , Gordon V.C. , Hildebrand B. , Lewis R.W. , Liebsch M. , Logemann P. , Osborne R. , Ponec M. , Régnier J.F. , Steiling W. , Walker A.P. , & Balls M. (1995). A prevalidation study on in vitro skin corrosivity testing. The report and recommendations of ECVAM workshop 6. ATLA 23, 219–255.

Fentem J. H. , Briggs D. , Chesné C. , Elliott G. R. , Harbell J. W. , Heylings J. R. , Portes P. , Roguet R. , van de Sandt J. J. M. , & Botham P. A. (2001). A prevalidation study on in vitro tests for acute skin irritation: results and evaluation by the Management Team. Toxicology in Vitro 15, 57–93.

Spielmann H. , Balls M. , Dupuis J. , Pape W.J. , Pechovitch G. , de Silva O. , Holzhütter H.G. , Clothier R. , Desolle P. , Gerberick F. , Liebsch M. , Lovell W.W. , Maurer T. , Pfannenbecker U. , Potthast J.M. , Csato M. , Sladowski D. , Steiling W. , & Brantom P. (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 Vitro 12, 305–327.

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

ECVAM (1998). Statement on the scientific validity of the EPISKIN™ test (an in vitro test for skin corrosivity). ATLA 26, 277–280.

ECVAM (1998). Statement on the scientific validity of the rat skin transcutaneous electrical resistance (TER) test (an in vitro test for skin corrosivity). ATLA 26, 275–277.

ECVAM (2001). Statement on the application of the EPIDERM® human skin model for skin corrosivity testing. ATLA 28, 365–367.