Role of chronic toxicology studies in revealing new toxicities

Regulatory Toxicology and Pharmacology

Volumn 82, Issue , 2016, Pages 94-98

  Galijatovic Idrizbegovic, Alema ^a   Miller, Judith E ^a   Cornell, Wendy D ^a   Butler, James A ^b   Wollenberg, Gordon K ^a   Sistare, Frank D ^a   DeGeorge, Joseph J ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

^b LINGUAMATICS LTD   (United Kingdom)

Author keywords

Chronic; Human safety risk; Preclinical species; Toxicology studies

Indexed keywords

ARTICLE; CHRONIC TOXICITY; CLINICAL DEVELOPMENT PLAN; CLINICAL TRIAL (TOPIC); DOG; DRUG DEVELOPMENT; DRUG INDICATION; DRUG RESEARCH; DRUG SAFETY; DRUG TOXICITY; HAPLORHINI; HUMAN; INCIDENCE; NONHUMAN; PRECLINICAL STUDY; PRIORITY JOURNAL; RISK ASSESSMENT; RODENT; TARGET ORGAN; TOXICITY TESTING; TREATMENT DURATION; TREATMENT WITHDRAWAL; ANIMAL; ANIMAL MODEL; DOSE RESPONSE; DRUG INDUSTRY; FACTUAL DATABASE; PROCEDURES; REPRODUCIBILITY; SPECIES DIFFERENCE; TIME FACTOR;

ANIMALS; DATABASES, FACTUAL; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG INDUSTRY; HUMANS; MODELS, ANIMAL; REPRODUCIBILITY OF RESULTS; RISK ASSESSMENT; SPECIES SPECIFICITY; TIME FACTORS; TOXICITY TESTS, CHRONIC; TOXICITY TESTS, SUBCHRONIC;

EID: 84998817109     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2016.10.010     Document Type: Article

References (11)

1. Bailey, J., Thew, M., Balls, M., An analysis of the use of dogs in predicting human toxicology and drug safety. ATLA 41 (2013), 335–350.
2. Bennett, M., Fried, J., Kehoe, M., Voskresenskaya, N., Professional Microsoft Search: FAST Search, Share Point Search, and Search Server. first ed., 2010.
3. Broadhead, C.L., Betton, G., Combes, R., Damment, S., Everett, D., Garner, C., Godsafe, Z., Healing, G., Heywood, R., Jennings, M., Lumley, C., Oliver, G., Smith, D., Straughan, D., Topham, J., Wallis, R., Wilson, S., Buckley, P., Prospects for reducing and refining the use of dogs in the regulatory toxicity testing of pharmaceuticals. Hum. Exp. Toxicol. 19:8 (2000), 440–447.
4. DeGeorge, J.J., Meyers, L.L., Takahashi, M., Contrera, J.F., The duration of non-rodent toxicity studies for pharmaceuticals. Toxicol. Sci. 49 (1999), 143–155.
5. Hassan, M., Brown, R.D., Varma-O'Brien, S., Rogers, D., Cheminformatics analysis and learning in a data pipelining environment. Mol. Divers. 10 (2006), 283–299.
6. ICH M3 (R2), Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals. 2009.
7. ICH S1 Concept Paper, Rodent Carcinogenicity Studies for Human Pharmaceuticals. 14 November 2012.
8. Milward, D., Bjäreland, M., Hayes, W., Maxwell, M., Oberg, L., Tilford, N., Thomas, J., Hale, R., Knight, S., Barnes, J., Ontology-based interactive information extraction from scientific abstracts. Comp. Funct. Genom. 6 (2005), 67–71.
9. Reddy, M.V., Sistare, F.D., Christensen, J.S., Deluca, J.G., Wollenberg, G.K., DeGeorge, J.J., An evaluation of chronic 6- and 12-month rat toxicology studies as predictors of 2-year tumor outcome. Vet. Pathol. 47:4 (2010), 614–629.
10. Sistare, F.D., Morton, D., Alden, C., Christensen, J., Keller, D., Jonghe, S.D., Storer, R.D., Reddy, M.V., Kraynak, A., Trela, B., Bienvenu, J.G., Bjurström, S., Bosmans, V., Brewster, D., Colman, K., Dominick, M., Evans, J., Hailey, J.R., Kinter, L., Liu, M., Mahrt, C., Marien, D., Myer, J., Perry, R., Potenta, D., Roth, A., Sherratt, P., Singer, T., Slim, R., Soper, K., Fransson-Steen, R., Stoltz, J., Turner, O., Turnquist, S., van Heerden, M., Woicke, J., DeGeorge, J.J., An analysis of pharmaceutical experience with decades of rat carcinogenicity testing: support for a proposal to modify current regulatory guidelines. Toxicol. Pathol. 39:4 (2011), 716–744.
11. Wiggins, B. (2000; digitized Feb. 24, 2010). Effective Document Management: Unlocking Corporate Knowledge. Indiana University, IN: Gower.