Balls, M., Amcoff, P., Bremer, S., et al. (2006). The principles of weight of evidence validation of test methods and test strategies. Altern. Lab. Anim. 34, 603-620.
Balls, M., Blaauboer, B.J., Fentem, J.H., et al. (1995). Practical aspects of the validation of toxicity test procedures. The report and recommendations of the ECVAM Workshop 5. Altern. Lab. Anim. 23, 129-147.
Balls, M., & Karcher, W. (1995). The validation of alternative test methods. Altern. Lab. Anim. 23, 884-886.
Blaauboer, B.J., Barratt, M.D. & Houston, J.B. (1999). The integrated use of alternative methods in toxicological risk evaluation. ECVAM Integrated Testing Strategies Task Force Report 1. Altern. Lab. Anim. 27, 229-237.
Coecke, S., Balls, M., Bowe, G., et al. (2005). Guidance on Good Cell Culture Practice. A Report of the Second ECVAM Task Force on Good Cell Culture Practice. Altern. Lab. Anim. 33, 261-287.
Cooper-Hannan, R., Harbell, J.W., Coecke, S., et al. (1999). The principles of Good Laboratory Practice: Application to in vitro toxicology studies. ECVAM Workshop Report 37. Altern. Lab. Anim. 27, 539-577.
Curren, R.D., Southee, J.A., Spielmann, H., et al. (1995).The role of prevalidation in the development, validation and acceptance of alternative methods. Altern. Lab. Anim. 23, 211-217.
ECVAM. (2002). The principles and procedures of validation. (Eds. A.P. Worth & M. Balls). Altern. Lab. Anim. 30, Suppl. 1, 13-19.
ECVAM. (2005). Executive summary. (Eds. C. Eskes & V. Zuang). Altern. Lab. Anim. 33, Suppl. 1, 7-18.
Fentem, J.H. & Balls, M. (1997). The ECVAM approach to validation. In L. F. M. van Zutphen & M. Balls (Eds.), Animal Alternatives, Welfare and Ethics (pp. 1083-1089). Amsterdam: Elsevier Science B.V.
Hartung, T., Balls, M., Bardouille, C., et al. (2002). Good Cell Culture Practice. ECVAM Good Cell Culture Practice Task Force Report 1. Altern. Lab. Anim. 30, 407-414.
Hartung, T., Bremer, S., Casati, S., et al. (2003) ECVAM's response to the changing political environment for alternatives: Consequences of the European Union chemicals and cosmetics policies. Altern. Lab. Anim. 31, 473-481.
Hartung, T., Bremer, S., Casati, S., et al. (2004). A modular approach to the ECVAM principles on test validity. Altern. Lab. Anim. 32, 467-472.
ICCVAM. (2001). ICCVAM procedures for test methods that have been endorsed by ECVAM. Available here.
Kojima, H. (2006). Current activities on alternative research in Japan. Available here.
NICEATM-ICCVAM. (2003). ICCVAM guidelines for the nomination and submission of new, revised and alternative test methods. NIH Publication No. 03-4508. Available here.
NICEATM-ICCVAM. (2007a). About the Interagency Coordinating Committee on the Validation of Alternative Methods. Available here.
NICEATM-ICCVAM. (2007b). Good Laboratory Practice resources. Available here.
NIEHS. (1997). Validation and regulatory acceptance of toxicological methods: A report of the ad hoc Interagency Coordinating Committee on the Validation of Alternative Methods. NIH Publication No. 97-3981. NIEHS, Research Triangle Park, NC. Available here.
OECD. (1996). Report of the OECD workshop on harmonisation of validation and acceptance criteria for alternative toxicological test methods. (Solna report). OECD, Paris, 60 pp. [ENV/MC/CHEM(96)9]
OECD. (2002). Final report of the OECD workshop on harmonization of validation and acceptance criteria for alternative toxicological test methods. Long abstract.
OECD. (2004). Report from the expert group on (Quantitative) Structure-Activity Relationships [(Q)SARs] on the principles for the validation of (Q)SARs. Series on Testing and Assessment, No. 49. OECD, Paris. Available here.
OECD. (2005). Guidance document on the validation and international acceptance of new or updated test methods for hazard assessment, Series on Testing and Assessment, No. 34. OECD, Paris. Available here.
OECD. (2007). Guidance document on the validation of (Quantitative) Structure-Activity Relationships [(Q)SAR] models. Series on Testing and Assessment, No. 69. OECD, Paris. Available here.
OECD. (n.d.). OECD series on principles of Good Laboratory Practice and compliance monitoring. Available here.
Ohno, Y. (2004). Validation and regulatory acceptance of alternative methods for toxicity evaluation. Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku. 122, 1-9.
Park, K.L. (2006). Current status of alternative study in NITR. Available here.
Schechtman, L.M. (2006). ICCVAM and the evaluation of alternative test methods: Current practices and activities. Available here.
Schechtman, L.M. & Stokes, W.S. (2002). ECVAM-ICCVAM: Prospects for future collaboration. Altern. Lab. Anim. 30, Suppl. 2, 227-36.
Spielmann, H. (2002). Would Sisyphus meet the challenges of validation from test development to global regulatory acceptance? In: Progress in the Reduction, Refinement and Replacement of Animal Experimentation (Eds. M. Balls, A.-M. van Zeller & M.E. Halder). Elsevier, Amsterdam, 27-38.
Spielmann, H. & Liebsch, M. (2001). Lessons learned from validation of in vitro toxicity test: From failure to acceptance into regulatory practice. Toxicol. In Vitro. 15, 585-590.
Stokes, W.S., Schechtman, L.M. & Hill, R.N. (2002). The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM): A review of the ICCVAM test method evaluation process and current international collaborations with the European Centre for the Validation of Alternative Methods (ECVAM). Altern. Lab. Anim. 30, Suppl. 2, 23-32.
Worth, A.P. & Balls, M. (2001). The role of ECVAM in promoting the regulatory acceptance of alternative methods in the European Union. Altern. Lab. Anim. 29, 525-535.
|
