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Leakey JEA, Allaben WT, Dunnick JK, et al. NTP Genetically Modified Model Report on the Toxicology and Carcinogenicity Studies of 3’-Azido-3’-Deoxythymidine (CASRN 30516-87-1) in Genetically Modified C3B6.129F1-Trp53tm1Brd N12 Haploinsufficient Mice (In Utero and Postnatal Gavage Study): NTP GMM 14 [Internet]. Research Triangle Park (NC): National Toxicology Program; 2013 Oct.
NTP Genetically Modified Model Report on the Toxicology and Carcinogenicity Studies of 3’-Azido-3’-Deoxythymidine (CASRN 30516-87-1) in Genetically Modified C3B6.129F1-Trp53tm1Brd N12 Haploinsufficient Mice (In Utero and Postnatal Gavage Study): NTP GMM 14 [Internet].
Show detailsThe study on 3′-azido-3′-deoxythymidine was conducted at the Food and Drug Administration’s (FDA) National Center for Toxicological Research (NCTR) under an interagency agreement between the FDA and the National Institute of Environmental Health Sciences (NIEHS). The studies were monitored by a Toxicology Study Selection and Review Committee composed of representatives from the NCTR and other FDA centers, NIEHS, and other ad hoc members from other governmental agencies and academia. The interagency agreement was designed to use the staff and facilities of the NCTR in the testing of FDA priority chemicals and to provide FDA scientists and regulatory policymakers with information for hazard identification and risk assessment.
National Center for Toxicological Research, Food and Drug Administration
Conducted studies, evaluated and interpreted results and pathology findings, and reported findings
- J.E.A. Leakey, Ph.D., Study Scientist
- W.T. Allaben, Ph.D., Co-Study Scientist
- J.K. Dunnick, Ph.D., Co-Study ScientistNational Toxicology Program
- F.W. Lee, Ph.D., Co-Study Scientist
- S.M. Lewis, Ph.D., Co-Study Scientist
- P.C. Howard, Ph.D.
- C.C. Weis, B.S.
Provided microbiological support
- D.D. Paine, B.S.
Conducted chemical analysis of the purity of the test chemical
- S.M. Billedeau, M.S.
- B.R. Brown, B.S.
- J.P Freeman, Ph.D.
- J. Moody, B.S.
- L.K. Schoenbachler, Ph.D.
- P.H. Siitonen, B.S.
Conducted quality assurance audits
- S.J. Culp, Ph.D.
- J.M. Fowler, B.S.
- R.D. Smith, B.S.
Provided statistical analysis
- S. Appana, M.S.
- S.J. Baek, Ph.D.
- R.P. Felton, M.S.
- B.T. Thorn, M.S.
Bionetics Corporation
Prepared animal feed and cared for mice
- C.J. Cain
- J.W. Carson, B.S.
- A. Matson, B.S.
Z-Tech Corporation
Provided software systems development and data entry
- K.A. Carroll
- S.H. Green
Toxicologic Pathology Associates
Evaluated pathology findings
- P.W. Mellick, D.V.M., Ph.D.
- G.R. Olson, D.V.M., Ph.D.
- A.R. Warbritton
- L.P. Wiley, B.S.
Experimental Pathology Laboratories, Inc.
Provided pathology review
- M.H. Hamlin, II, D.V.M., Principal Investigator
- J.F. Hardisty, D.V.M.
- R.A. Miller, D.V.M., Ph.D.
NTP Pathology Working Group
Evaluated slides and contributed to pathology report on mice (March 28 and April 17, 2008)
- J.F. Hardisty, D.V.M., CoordinatorExperimental Pathology Laboratories, Inc.
- J.M. Cullen, V.M.D., Ph.D.North Carolina State University
- S.A. Elmore, D.V.M., M.S.National Toxicology Program
- D.E. Malarkey, D.V.M., Ph.D.National Toxicology Program
- P.W. Mellick, D.V.M., Ph.D.Toxicologic Pathology Associates
- R.A. Miller, D.V.M., Ph.D.Experimental Pathology Laboratories, Inc.
- G.R. Olson, D.V.M., Ph.D.Toxicologic Pathology Associates
NIEHS/FDA Interagency Agreement Project Officers
- P.C. Howard, Ph.D.National Center for Toxicological Research
- W.T. Allaben, Ph.D.National Center for Toxicological Research
- N.J. Walker, Ph.D.National Institute of Environmental Health Sciences
- J.R. Bucher, Ph.D.National Institute of Environmental Health Sciences
Biotechnical Services, Inc.
Prepared Report
- S.R. Gunnels, M.A., Principal Investigator
- L.M. Harper, B.S.
- E.S. Rathman, M.S.
- D.C. Serbus, Ph.D.
- CONTRIBUTORS - NTP Genetically Modified Model Report on the Toxicology and Carci...CONTRIBUTORS - NTP Genetically Modified Model Report on the Toxicology and Carcinogenicity Studies of 3’-Azido-3’-Deoxythymidine (CASRN 30516-87-1) in Genetically Modified C3B6.129F1-Trp53tm1Brd N12 Haploinsufficient Mice (In Utero and Postnatal Gavage Study)
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