The principles of good laboratory practice: Application to in vitro toxicology studies - The report and recommendations of ECVAM Workshop 37

Alternatives to Laboratory Animals

Volumn 27, Issue 4, 1999, Pages 539-577

  Cooper Hannan, Robin ^a   Harbell, John W ^b   Coecke, Sandra ^c   Balls, Michael ^c   Bowe, Gerard ^c   Červinka, Miroslav ^d   Clothier, Richard ^e   Hermann, Frauke ^f   Klahm, Lynn K ^g   De Lange, Jan ^c   Liebsch, Manfred ^h   Vanparys, Philippe ⁱ  

^a Qualitas   (United Kingdom)

^b Institute for in Vitro Sciences   (United States)

^c JOINT RESEARCH CENTRE   (Italy)

^d CHARLES UNIVERSITY   (Czech Republic)

^e UNIVERSITY OF NOTTINGHAM   (United Kingdom)

^f RCC Cytotest Cell Research   (Germany)

^g PROCTER AND GAMBLE COMPANY   (United States)

^h FEDERAL INSTITUTE FOR RISK ASSESSMENT   (Germany)

ⁱ JANSSEN RESEARCH FOUNDATION   (Belgium)

Author keywords

[No Author keywords available]

Indexed keywords

CONFERENCE PAPER; ENVIRONMENTAL PROTECTION; FOOD AND DRUG ADMINISTRATION; GOOD LABORATORY PRACTICE; HEALTH CARE FACILITY; INFORMATION PROCESSING; LABORATORY PERSONNEL; ORGANIZATION; PRIORITY JOURNAL; QUALITY CONTROL; RISK ASSESSMENT; TOXICITY TESTING; VALIDATION PROCESS;

EID: 0032817261     PISSN: 02611929     EISSN: None     Source Type: Journal    
DOI: 10.1177/026119299902700410     Document Type: Conference Paper

References (15)

1. ECVAM (1994). ECVAM News & Views. ATLA 22, 7-11.
2. OECD (1998). Organisation for Economic Cooperation and Development series on Principles of Good Laboratory Practice and compliance monitoring. Number 1. OECD Principles on Good Laboratory Practice (as revised in 1997), OECD Environmental Health and Safety Publications, Environment Directorate: ENV/MC/CHEM(98) 17. Paris, France: OECD.
3. OECD (1992). Environment Monograph No. 50, Series on Principles of Good Laboratory Practice and Compliance Monitoring: Number 6, The Application of the GLP Principles to Field Studies. Paris, France: OECD.
4. Stiles, T. (1997). The revised OECD principles of Good Laboratory Practice: a reflection upon the impact of the proposed changes on pre-clinical safety testing. Part 1. Scope, definition of terms, responsibilities. The Quality Assurance Journal 2, 13-18.
5. Stiles, T. (1997). The revised OECD Principles of Good Laboratory Practice: a reflection upon the impact of the proposed changes on pre-clinical safety testing. Part 2. Scope, definition of terms, responsibilities. The Quality Assurance Journal 2, 49-53.
6. 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., Speilmann, H. & Zucco, F. (1995). Practical aspects of the validation of toxicity test procedures. ATLA 23, 129-147.
7. Harbell, J.W., Southee, J.A. & Curren, R.D. (1997). The path to regulatory acceptance of in vitro methods is paved with the strictest scientific standards. In Animal Alternatives, Welfare and Ethics (ed. L.F.M van Zutphen & M. Balls), pp. 1177-1181. Amsterdam, The Netherlands: Elsevier.
8. Anon. (1999). Adapting to technical progress for the second time the Annex to Council Directive 88//320/EEC on the inspection and verification of Good Laboratory Practice (GLP). Commission Directive 1999/12/EC. Official Journal of the European Communities 77, 22-33.
9. OECD (1998). Organisation for Economic Cooperation and Development series on Principles of Good Laboratory Practice and compliance monitoring. Number 3 (Revised). Guidance for GLP monitoring authorities revised guidance for the conduct of laboratory inspections and study audit, Environment Monograph No. 111, OECD Environmental Health and Safety Publications: OECD/GD(95)67. Paris, France: OECD.
10. Anon. (1999). Adapting to technical progress the Principles of Good Laboratory Practice as specified in Council Directive 87/18/EEC on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances. Commission Directive 1999/11/EC. Official Journal of the European Communities 77, 8-21.
11. Balls, M. & Karcher, W. (1995). The validation of alternative test methods. ATLA 23, 884-886.
12. 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.
13. 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. 2. Results and evaluation by the Management Team. Toxicology in Vitro 12, 483-524.
14. Froud, S.J. & Luker, J. (1994). Good Laboratory Practice in the cell culture laboratory. In Basic Cell Culture: A Practical Approach (ed. J.M. Davis), pp. 273-286. Oxford, UK: Oxford University Press.
15. Cooper-Hannan, R. (1997). Good Laboratory Practice and study management for the validation of in vitro toxicity studies. ATLA 12, 527-537.