Mutagenicity of recombinant antihemophilic factor (GC-γAHF)

Arzneimittel-Forschung/Drug Research

Volumn 50, Issue 3, 2000, Pages 316-321

  Shin, Minki ^a   Kim, Byungsoo ^b   Mar, Woongcheon ^a   Fang, Mingzhu ^a   Son, Jangwon ^a   Kim, Minyoung ^a   Kwak, Hyungil ^a   Bae, Miok ^a   Byun, Taeho ^c   Park, Songyong ^c   Chun, Bokhwan ^c   Byun, Jonghwan ^c   An, Gilhwan ^d   Lee, Bumjoon ^a   Cho, Myunghaing ^a,e  

^a Seoul National University   (South Korea)

^b Yonsei University   (South Korea)

^c Green Cross Company   (South Korea)

^d SunMoon University   (South Korea)

^e Seoul National Unverisity   (South Korea)

Author keywords

Ames test; Antihemophilic factor; Chromosomal aberration assay; Micronucleus assay; Supravital micronucleus assay

Indexed keywords

DRUG VEHICLE; HISTIDINE; MITOMYCIN C; RECOMBINANT BLOOD CLOTTING FACTOR 8;

AMES TEST; ANIMAL CELL; ANIMAL EXPERIMENT; ARTICLE; BONE MARROW CELL; CHINESE HAMSTER; CHROMOSOME ABERRATION; CONTROLLED STUDY; ERYTHROCYTE; LUNG FIBROBLAST; LYMPHOCYTE; MALE; METABOLIC ACTIVATION; MICRONUCLEUS TEST; MOUSE; MUTAGENICITY; NONHUMAN; SALMONELLA TYPHIMURIUM;

EID: 1642524650     PISSN: 00044172     EISSN: None     Source Type: Journal    
DOI: 10.1055/s-0031-1300207     Document Type: Article

References (29)

1. Aledort, L. M., Current concepts in the diagnosis and management of hemophilia. Hosp. Pract. 7, 81 (1982)
2. Arnold, D., Virus safety considerations for recombinant factor VIII(rFVIII, Kogenate). Haemophilia 1, 22 (1995)
3. Berntorp, E., Second generation, B-domain deleted recombinant factor VIII. Thrombosis and Haemostasis 78, 256 (1997)
4. Buchanan, G. R., Coagulation factors. In: Hematology of Infancy and Childhood, vol. 2, pp. 1536-1551. Saunders, Philadelphia (1981)
5. Eaton, D., Hass, P., Riddle, L. et al., Characterization of recombinant human factor VIII. J. Biol. Chem. 262, 3285 (1987)
6. Eis-Hubinger, A. M., Sasowski, V., Brackmann, H. H. et al., Parvovirus B19 DNA is frequently present in recombinant coagulation factor VIII products. Thromb. Haemost. 76, 1120 (1996)
7. Fay, P., Factor VIII structure and function. Thromb. Haemost. 70 63 (1993)
8. Frosch, P. J., Cutaneous irritation. In: Contact Dermatitits, R. J. G. Rycroft, T. Menne, P. J. Frosch et al. (eds.), pp. 28-61, Springer Verlag, Berlin (1992)
9. Greener, Y., Jesmok, G., Grove, D. et al., Assessment of potential toxic effects of treated hemofil injection in rat and mice and on the systemic hemodynamics in dogs. J. Toxicol. Environ. Health 15, 801 (1985)
10. Guideline for Safety Tests of Drugs: FDA, Korea, Provision # 1996-8 (1996. 4. 16)
11. Han, H. R., Lee, J. K., Lee, C. W., The erythrocytes and their disorders. In: Veterinary Clinical Pathology, H. R. Han (ed.), pp. 126-159. Kijeon, Seoul (1982)
12. Hayashi, M., Morota, T., Kodama, Y. et al., The micronucleus assay with mouse peripheral blood reticulocytes using acridine orange-coated slides. Mutat. Res. 245, (1990)
13. Hoyer, L. W., Hemophilia A, N. Engl. J. Med. 330, 38 (1994)
14. Joyce, M., Gary, O., Kit, G. et al., Pharmacokinetics and interspecies scaling of recombinant human factor VIII. Toxicol. Appl. Pharmacol. 136, 75 (1996)
15. Kasper, C. K., The factor VIII complex: Structure and function. Blood 1, 1 (1981)
16. Kim, B. S., Cho, M. H., Statistical Analysis of in vivo rodent micronucleus assay. Environ. Mol. Mutagen. 33 (Suppl. 30), 36 (1999)
17. Kim, B. S., Kim, H. J., Cho, M. H., The statistical analysis of in vitro chromosome aberration assay. Bull. Int. Statist. Inst. 2, 131 (1999)
18. Kim, B. S., Margolin, B. H., Statistical Methods for the Ames Salmonella assay: A Review. Mutat. Res. 436, 113 (1999)
19. Laurian, Y., Dussaix, E., Rothschild, C. et al., Detection of human parvovirus B19 DNA by polymerase chain reaction in different factor VIII concentrates: Correlation with infectivity XXII Int. Congr. Wld. Fed. Hemophilia, Dublin. Haemophilia 2, 97 (1996)
20. Maron, D. M., Ames, B. N., Revised methods for the Salmonella mutagenecity test, Mutat. Res., 113, 173 (1983)
21. Morfini, M., Nannucci, P., Tecconi, P. et al., Pharmacokinetics of monoclonally purified and recombinant factor VIII in patients with severe von Willebrand disease. Thromb. Haemost. 70, 270 (1993)
22. Mosmann, T., Rapid colorimetric assay for cellular growth and survival; Application to proliferation and cytotoxicity assay. J. Immunol. Methods 65, 55 (1983)
23. Oscar, D., Ratnoff, D. et al., Antihemophilic factor (Factor VIII). Ann. Intern. Med. 88, 403 (1978)
24. Schmid, W., The micronucleus test. Mutat. Res. 31, 9 (1975)
25. The Collaborative Study Group for the Micronucleus Test: Micronucleus test with mouse peripheral blood erythrocytes by acridine orange supravital staining: The summary report of the 5th collaborative study by CSGMT/JEMS.MMS. Mutat. Res. 278, 83 (1992)
26. Vehar, G., Eaton, D., Rodriquez, H. et al., Structure of human factor VIII. Nature 312, 337 (1984)
27. Vehar, G., Eaton, D., Factor VIII structure and function. In Coagulation and bleeding Disorders; The Role of Factor VIII and von Willebrand Factor, T. S. Zimmerman, Z. Rugger (eds.), pp. 1-21. Dekker, New York (1989)
28. Wahlberg, J. E., Clinical overview of irritant dermatitis. In: The Irritant Contact Dermatitis Syndrome, P. G. M. Valk, H. I. Maibach, pp. 1-6. CRC Press, Boca Raton, FL (1996)
29. Wood, W., Capon, D., Simonsen, C., Expression of active human factor VIII from recombinant DNA clones. Nature 312, 330 (1984)