Performance and data interpretation of the in vivo comet assay in pharmaceutical industry: EFPIA survey results

Mutation Research - Genetic Toxicology and Environmental Mutagenesis

Volumn 775-776, Issue , 2014, Pages 81-88

  van der Leede, Bas jan ^a   Doherty, Ann ^b   Guérard, Melanie ^c   Howe, Jonathan ^d   O'Donovan, Mike ^e   Plappert Helbig, Ulla ^f   Thybaud, Véronique ^g  

^a JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

^b ASTRAZENECA   (United Kingdom)

^c Pharma Research and Early Development   (Switzerland)

^d GLAXOSMITHKLINE   (United Kingdom)

^e Consultant Genetic Toxicologist ^*  (United Kingdom)

^f NOVARTIS PHARMA AG   (Switzerland)

^g SANOFI   (France)

Author keywords

Comet assay; EFPIA; Genotoxicity; Regulatory safety testing; Survey

Indexed keywords

DNA; DRUG;

ANIMAL CELL; ARTICLE; CARCINOGENICITY; COMET ASSAY; CONTROLLED STUDY; CYTOTOXICITY; DATA PROCESSING; DNA CROSS LINKING; DNA DAMAGE; DRUG INDUSTRY; FOLLOW UP; GENOTOXICITY; HEALTH CARE SURVEY; MICRONUCLEUS TEST; MOUSE; NONHUMAN; RAT; ANIMAL; EUROPE; GENETICS; INFORMATION PROCESSING; ORGANIZATION AND MANAGEMENT; PRACTICE GUIDELINE; PROCEDURES; RODENT; STATISTICS AND NUMERICAL DATA;

ANIMALS; COMET ASSAY; DATA COLLECTION; DNA DAMAGE; DRUG INDUSTRY; EUROPE; GUIDELINES AS TOPIC; MICRONUCLEUS TESTS; RODENTIA;

EID: 84912017156     PISSN: 13835718     EISSN: 18793592     Source Type: Journal    
DOI: 10.1016/j.mrgentox.2014.09.008     Document Type: Article

References (21)

1. Tice R.R., Agurell E., Anderson D., Burlinson B., Hartmann A., Kobayashi H., Miyamae Y., Rojas E., Rye J.C., Sasaki Y.F. Single cell gel/comet assay: guidelines for in vitro and in vivo genetic toxicity testing. Environ. Mol. Mutagen. 2000, 35:206-221.
2. Hartmann A., Agurell E., Beevers C., Brendler-Schwaab S., Burlinson B., Clay P., Collins A., Smith A., Speit G., Thybaud V., Tice R.R. Recommendations for conducting the in vivo alkaline comet assay. Mutagenesis 2003, 18:45-51.
3. Burlinson B., Tice R.R., Speit G., Agurell E., Brendler-Schwaab S.Y., Collins A.R., Escobar P., Honma M., Kumaravel T.S., Nakajima M., Sasaki Y.F., Thybaud V., Uno Y., Vasquez M., Hartmann A. Fourth international workshop on genotoxicity testing: results of the in vivo comet assay workgroup. Mutat. Res. 2007, 627:31-35.
4. Smith C.C., Adkins D.J., Martin E.A., O'Donovan.M.R. Recommendations for design of the rat comet assay. Mutagenesis 2008, 23:233-240.
5. OECD Guidelines for Testing of Chemicals; Guideline no. 489: In Vivo Mammalian Alkaline Comet Assay. Adopted, September 26, 2014.
6. Committee on Mutagenicity of Chemicals in Food, Consumer Products and the Environment (COM) Guidance on a Strategy for Testing of Chemicals for Mutagenicity 2000.
7. U.S.Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Guidance for Industry and Review Staff: Recommended Approaches to Integration of Genetic Toxicity Study Results 2006.
8. European Medicines Agency (EMA) Note for ICH guideline S2(R1) on genotoxicity testing and data interpretation for pharmaceuticals intended for human use (EMA/CHMP/ICH/126642/2008) June 2012.
9. Kirkland D., Speit G. Evaluation of the ability of a battery of three in vitro genotoxicity tests to discriminate rodent carcinogens and non-carcinogens. III. Appropriate follow-up testing in vivo. Mutat. Res. 2008, 654:114-132.
10. Rothfuss A., O'Donovan M., De Boeck M., Brault D., Czich A., Custer L., Hamada S., Plappert-Helbig U., Hayashi M., Howe J., Kraynak A.R., van der Leede B.J., Nakajima M., Priestley C., Thybaud V., Saigo K., Sawant S., Shi J., Storer R., Struwe M., Vock E., Galloway S. Collaborative study on fifteen compounds in the rat-liver comet assay integrated into 2- and 4-week repeat dose studies. Mutat. Res. 2010, 702:40-69.
11. Bowen D.E., Whitwell J.H., Lillford L., Henderson D., Kidd D., Mc Garry S., Pearce G., Beevers C., Kirkland D.J. Evaluation of a multi-endpoint assay in rats, combining the bone-marrow micronucleus test, the comet assay and the flow-cytometric peripheral blood micronucleus test. Mutat. Res. 2011, 722:7-19.
12. Galloway S., Lorge E., Aardema M.J., Eastmond D., Fellows M., Heflich R., Kirkland D., Levy D.D., Lynch A.M., Marzin D., Morita T., Schuler M., Speit G. Workshop summary: top concentration for in vitro mammalian cell genotoxicity assays; and report from working group on toxicity measures and top concentration for in vitro cytogenetics assays (chromosome aberration and micronucleus). Mutat. Res. 2011, 723:77-83.
13. Pfuhler S., Fellows M., van Benthem J., Corvi R., Curren R., Dearfield K., Frötschl R., Elhajouji A., Le Hégarat L., Kasamatsu T., Kojima H., Ouédraogo G., Scott A., Speit G. In vitro genotoxicity test approaches with better predictivity: summary of an IWGT workshop. Mutat. Res. 2011, 723:101-107.
14. Guerard M., Marchand C., Plappert-Helbig.U. Influence of experimental conditions on data variability in the liver comet assay. Environ. Mol. Mutagen. 2014, 55:114-121.
15. Hayashi M., Dearfield K., Kasper P., Lovell D., Martus H.J., Thybaud V. Compilation and use of genetic toxicity historical control data. Mutat. Res. 2011, 723:87-90.
16. OECD Reports of the JaCVAM Initiative International Pre-validation and Validation Studies of the In Vivo Rodent Alkaline Comet Assay for the Detection of Genotoxic Carcinogens. Series on Testing and Assessment, Nos. 193 and 194 2014, OECD Publishing, Paris.
17. Pfuhler S., Wolf H.U. Detection of DNA-crosslinking agents with the alkaline comet assay. Environ. Mol. Mutagen. 1996, 27:196-201.
18. Merk O., Speit G. Detection of crosslinks with the comet assay in relation to genotoxicity and cytotoxicity. Environ. Mol. Mutagen. 1999, 33:167-172.
19. Nesslany F., Zennouche N., Simar-Meintières S., Talahari I., NKili-Mboui E.N., Marzin D. In vivo comet assay on isolated kidney cells to distinguish genotoxic carcinogens from epigenetic carcinogens or cytotoxic compounds. Mutat. Res. 2007, 630:28-41.
20. Spanswick V.J., Hartley J.M., Hartley J.A. Measurement of DNA interstrand crosslinking in individual cells using the single cell gel electrophoresis (comet) assay. Methods Mol. Biol. 2010, 613:267-282.
21. Wu J.H., Jones N.J. Assessment of DNA interstrand crosslinks using the modified alkaline comet assay. Methods Mol. Biol. 2012, 817:165-181.