Carcinogenicity Evaluation: Comparison of Tumor Data from Dual Control Groups in the CD–1 Mouse

Toxicologic Pathology

Volumn 35, Issue 4, 2007, Pages 562-575

  Baldrick, Paul ^a   Reeve, Lesley ^a  

^a UK   (United Kingdom)

Author keywords

benign and malignant neoplasms; carcinogenicity; CD 1 mouse; dual control groups; genetic drift; survival

Indexed keywords

ANIMAL EXPERIMENT; ANIMAL MODEL; ARTICLE; CANCER INCIDENCE; CANCER RISK; CANCER SURVIVAL; CARCINOGENICITY; COMPARATIVE STUDY; CONTROLLED STUDY; FEMALE; GENETIC DRIFT; MALE; MOUSE; NONHUMAN; PRIORITY JOURNAL; RISK ASSESSMENT; TIME SERIES ANALYSIS;

ANIMALS; CARCINOGENICITY TESTS; CARCINOGENS; DATABASES, FACTUAL; FEMALE; MALE; MICE; MICE, INBRED ICR; NEOPLASMS; NEOPLASMS, EXPERIMENTAL; RISK ASSESSMENT; RODENT DISEASES; SEX CHARACTERISTICS; SURVIVAL ANALYSIS;

RATTUS; RODENTIA;

EID: 34250364820     PISSN: 01926233     EISSN: None     Source Type: Journal    
DOI: 10.1080/01926230701347330     Document Type: Article

References (24)

1. Baldrick P Carcinogenicity evaluation: comparison of tumor data from dual control groups in the Sprague–Dawley rat Toxicol Pathol 2005 33 283 91
2. CDER Guidance for industry: Statistical aspects of the design, analysis, and interpretation of chronic rodent carcinogenicity studies of pharmaceuticals 2001 Issued as draft document in May 2001. Available at: 〈http://www.fda.gov/cder/guidance〉
3. Chandra M Frith CH Spontaneous neoplasms in aged CD–1 mice Toxicol Lett 1992 61 67 74
4. Contrera JF Jacobs AC DeGeorge JJ Carcinogenicity testing and the evaluation of regulatory requirements for pharmaceuticals Reg Toxicol Pharm 1997 25 2 130 45
5. CPMP/SWP/2877/00 Note for guidance on carcinogenic potential. Operational January 2003 Available at: 〈http://www.eudra.org/humandocs〉
6. Criver Spontaneous neoplastic lesions in Crl:CD–1BR mouse 1995 March 1995 Charles River Laboratories 〈www.criver.com/flex_content_area/documents/rm_rm_r_lesions_crlcd_1_icr_mouse.pdf〉
7. Criver Spontaneous neoplastic lesions in Crl:CD–1(ICR) mouse in control groups from 18 month to 2 year studies 2005 March 2005 Charles River Laboratories 〈www.criver.com/flex_content_area/documents/rm_rm_r_lesions_crlcd_1_icr_mouse.pdf〉
8. Fairweather WR Bhattacharyya A Ceuppens PP Heimann G Hothorn LA Kodell RL Lin KK Mager H Middleton BJ Slob W Soper KA Stallard N Ventre J Wright J Biostatistical methodology in carcinogenicity studies Drug Inform Jour 1998 32 401 21
9. FDA Redbook Toxicological principles for the safety assessment of food ingredients, January 2006. IV.C.6 Carcinogenicity studies with rodents 2000 US Food and Drug Administration, Office of Food Additive Safety
10. Gopinath C Spontaneous tumor rates: Their use to support rodent bioassays Toxicol Pathol 1994 22 2 160 4
11. Greim H Gelbke HP Reuter U Thielmann HW Edler L Evaluation of historical controls in carcinogenicity studies Hum Exp Tox 2003 22 541 9
12. Hardisty JF Factors influencing laboratory animal spontaneous tumor profiles Toxicol Pathol 1985 13 2 95 104
13. Hooks W Groom CJ Stewart JK In–life parameters and tumour data from Charles River Crl:CD–1(ICR)BR mouse dietary and oral gavage tumorigenicity studies terminated after two years Toxicol Sci 2005 84 S–1 1639
14. Haseman JK Huff J Boorman GA Use of historical control data in carcinogenicity studies in rodents Toxicol Pathol 1984 12 2 126 35
15. Haseman JK Winbush JS O’Donnell MW Jr Use of dual control groups to estimate false positive rates in laboratory animal carcinogenicity studies Fund Appl Toxicol 1986 7 4 573 84
16. Haseman JK Hailey JR Morris RW Spontaneous neoplasm incidences in Fischer 344 rats and B6C3F1 mice in two–year carcinogenicity studies: a National Toxicology Program update Toxicol Pathol 1998 26 3 428 41
17. ICH S1A Guideline on the need for carcinogenicity studies of pharmaceuticals. Operational July 1996 Available at: 〈http://www.eudra.org/humandocs〉
18. ICH S1B Testing for carcinogenicity of pharmaceuticals. Operational February 1998 Available at: 〈http://www.eudra.org/humandocs;〉
19. ICH S1C Dose selection for carcinogenicity studies of pharmaceuticals. Operational March 1995 Available at: 〈http://www.eudra.org/humandocs〉
20. ICH S1C(R) Guidance on dose selection for carcinogenicity studies of pharmaceuticals: Addendum on a limit dose and related notes. Operational December 1997 Available at: 〈http://www.eudra.org/humandocs〉
21. Maita K Hirano M Harada T Mitsumori K Yoshida A Takahashi K Nakashima N Kitazawa T Enomoto A Inui K Shirasu Y Mortality, major cause of moribundity and spontaneous tumors in CD–1 mice Toxicol Pathol 1988 16 2 340 9
22. Selwyn MR Dual controls, p–value plots and the multiple testing issue in carcinogenicity studies Environ Health Perspect 1989 82 337 44
23. Son WC Factors contributory to early death of young CD–1 mice in carcinogenicity studies Toxicol Lett 2003 145 88 98
24. Son WC Gopinath C Early occurrence of spontaneous tumors in CD–1 mice and Sprague–Dawley rats Toxicol Path 2004 32 4 371 4