Practical aspects of designing and conducting validation studies involving multi-study trials

Advances in Experimental Medicine and Biology

Volumn 856, Issue , 2016, Pages 133-163

  Coecke, Sandra ^a   Bernasconi, Camilla ^a   Bowe, Gerard ^a   Bostroem, Ann Charlotte ^a   Burton, Julien ^a   Cole, Thomas ^a   Fortaner, Salvador ^a   Gouliarmou, Varvara ^a   Gray, Andrew ^b   Griesinger, Claudius ^a   Louhimies, Susanna ^c   Gyves, Emilio Mendoza De ^a   Joossens, Elisabeth ^a   Prinz, Maurits Jan ^c   Milcamps, Anne ^a   Parissis, Nicholaos ^a   Wilk Zasadna, Iwona ^a   Barroso, João ^a   Desprez, Bertrand ^a   Langezaal, Ingrid ^a   Liska, Roman ^a   Morath, Siegfried ^a   Reina, Vittorio ^a   Zorzoli, Chiara ^a   Zuang, Valérie ^a   more..

^a JOINT RESEARCH CENTRE   (Italy)

^b MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY   (United Kingdom)

^c EUROPEAN COMMISSION   (Belgium)

Author keywords

[No Author keywords available]

Indexed keywords

COMPUTER MODEL; EUROPEAN UNION; HAZARD ASSESSMENT; IN VITRO STUDY; LABORATORY; METHODOLOGY; PREDICTION; PRIORITY JOURNAL; QUANTITATIVE STRUCTURE ACTIVITY RELATION; RELIABILITY; RESPONSIBILITY; STATISTICAL ANALYSIS; VALIDATION STUDY; ANIMAL; ANIMAL TESTING ALTERNATIVE; PROCEDURES; TOXICITY TESTING;

ANIMAL TESTING ALTERNATIVES; ANIMALS; EUROPEAN UNION; RESEARCH DESIGN; TOXICITY TESTS; VALIDATION STUDIES AS TOPIC;

EID: 84988944739     PISSN: 00652598     EISSN: 22148019     Source Type: Book Series    
DOI: 10.1007/978-3-319-33826-2_5     Document Type: Chapter

References (30)

1. AGIT (2007) Arbeitsgruppe Informationstechnologie: guidelines for the validation of computerized systems in GLP 2007; Verified December 2014. http://www.therqa.com/committeesworking-parties/good-laboratory-practice/regulations-guidelines/agit-switzerland/
2. Baldeshwiler AM (2003) History of FDA good laboratory practices. Qual Assur J 7:157–161
3. Balls M (1995) Defining the role of ECVAM in the development, validation and acceptance of alternative tests and testing strategies. Toxicol In Vitro 9(6):863–869
4. Bouvier d’Yvoire M, Bremer S, Casati S, Ceridono M, Coecke S, Corvi R, Eskes C, Gribaldo L, Griesinger C, Knaut H, Linge JP, Roi A, Zuang V (2012) ECVAM and new technologies for toxicity testing. Adv Exp Med Biol 745:154–180
5. Coecke S, Balls M, Bowe G, Davis J, Gstraunthaler G, Hartung T, Hay R, Merten OW, Price A, Schechtman L, Stacey G, Stokes W (2005) Guidance on good cell culture practice. A report of the second ECVAM task force on good cell culture practice. Altern Lab Anim 33(3):261–287
6. Coecke S, Bowe G, Milcamps A, Bernasconi C, Bostroem A-C, Bories G, Fortaner TS, Gineste J-M, Gouliarmou V, Langezaal I, Liska R, Mendoza E, Morath S, Reina V, Wilk-Zasadna I, Whelan M (2014a) Considerations in the development of in vitro toxicity testing methods intended for regulatory use. In vitro toxicology systems. Springer, New York
7. Coecke S, Bowe G, Millcamps A, Bernasconi C, Bostroem AC, Bories G, Fortaner S, Gineste Jm, Gouliarmou V, Langezaal I, Liska R, Mendoza E, Morath S, Reina V, Wilk-Zasadna I, Whelan M (2014b) Considerations in the development of in vitro toxicity testing methods intended for regulatory use, Coecke S, et al (2014) In: Jennings P, Price A (eds) In vitro toxicology systems series: methods in pharmacology and toxicology. Springer, New York, pp 551–569
8. Council (1986) Directive 87/18/EEC of 18 December 1986 on the harmonisation of laws, regulations and administrative provisions relating to the application of principles of good laboratory practice and the verification of their applications for tests on chemical substances. OJ L 15, 17.1.1987, pp 29–30
9. Council (1988) Directive 88/320/EEC of 9 June 1988 on the inspection and verification of Good Laboratory Practice (GLP). OJ L 145, 11.6.1988, pp 35–37
10. European Parliament and Council (2004a) Directive 2004/10/EC of 11 February 2004 on the harmonization 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. OJ L 50, 20.2.2004, pp 44–59
11. European Parliament and Council (2004b) Directive 2004/9/EC of 11 February 2004 on the inspection and verification of good laboratory practice (GLP). OJ L 50, 20.2.2004, pp 28–43
12. European Parliament and Council (2006) Regulation No. 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency
13. European Parliament and Council (2009) Directive 2009/41/EC on the contained use of genetically modified micro-organisms (GMMs). OJ L 125/75, 21.5.2009, pp 75–97
14. European Parliament and Council (2010) Directive 2010/63/EU of 22 September 2010 on the protection of animals used for scientific purposes. OJ L 276, 20.10.2010, pp 33–79
15. ECHA—European Chemical Agency (2014) Questions and Answers, REACH, Information requirements, test methods and quality of data, Version 1. http://echa.europa.eu/qa-display/-/qadisplay/5s1R/view/reach/Informationrequirementstestmethodsandqualityofdata
16. Gupta K, Rispin A, Stitzel K, Coecke S, Harbell J (2005) Ensuring quality of in vitro alternative test methods: issues and answers. Regul Toxicol Pharmacol 43:219–224
17. OECD (1981) Decision of the Council concerning the Mutual Acceptance of Data in the Assessment of Chemicals, C(81)30/FINAL
18. OECD (1989) Decision-Recommendation of the Council on Compliance with Principles of Good Laboratory Practice, C(89)87/FINAL
19. OECD (1995) OECD series on GLP and Compliance monitoring. Number 10. GLP consensus document on “The application of the principles of GLP to computerised systems”
20. OECD (2004) OECD series on GLP and Compliance monitoring. Number 14. GLP Advisory Document on “The application of the principles of GLP to computerised systems”
21. OECD (2005) OECD series on testing and assessment. Number 34. Guidance document on the validation and international acceptance of new or updated test methods for hazard assessment. ENV/JM/MONO(2005)14
22. OECD (2012) OECD QSAR toolbox. http://qsartoolbox.org
23. PIC/S (2007) Good Practices for the Computerised systems in regulated “GXP” environments. Verified December 2014. http://www.picscheme.org/pdf/27_pi-011-3-recommendation-on--computerised-systems.pdf
24. Rispin A, Harbell JW, Klausner M, Jordan FT, Coecke S, Gupta K, Stitzek K (2004) Quality assurance for in vitro alternative test methods: quality control issues in test kit production. Altern Lab Anim Suppl 1:725–729
25. Seiler JP (2005) Good laboratory practice. Springer, Berlin
26. Tice RR, Austin CP, Kavlock RJ, Bucher JR (2013) Improving the human hazard characterization of chemicals: a Tox21 update. Environ Health Perspect 121:756–765
27. Turnheim D (2008) Current state of the implementation of the OECD GLP principles in the OECD member countries and non-member economies in light of the outcome of the 1998–2002 pilot project of mutual joint visits. Ann Ist Super Sanità 44(4):327–330
28. US EPA (Environmental Protection Agency) (2010a) ToxCastTM data sets and published research. http://epa.gov/ncct/toxcast
29. US EPA (Environmental Protection Agency) (2010b) Tox21. http://epa.gov/ncct/Tox21
30. Vedani A, Smiesko M, Spreafico M, Peristera O, Dobler M (2009) Virtual ToxLab— in silico prediction of the toxic (endocrine disrupting) potential of drugs, chemicals and natural products: two years and 2000 compounds of experience: a progress report. ALTEX 26:167–176