Regulatory Forum Opinion Piece*: Retrospective Evaluation of Doses in the 26-week Tg.rasH2 Mice Carcinogenicity Studies: Recommendation to Eliminate High Doses at Maximum Tolerated Dose (MTD) in Future Studies.

Paranjpe, Madhav G; Denton, Melissa D; Vidmar, Tom J; Elbekai, Reem H

Paranjpe, Madhav G; Denton, Melissa D; Vidmar, Tom J; Elbekai, Reem H.

Affiliation

Paranjpe MG; BioReliance by SAFC, Rockville, Maryland, USA madhav.paranjpe@bioreliance.com.
Denton MD; BioReliance by SAFC, Rockville, Maryland, USA.
Vidmar TJ; BioSTAT Consultants, Inc., Portage, Michigan, USA.
Elbekai RH; BioReliance by SAFC, Rockville, Maryland, USA.

Toxicol Pathol ; 43(5): 611-20, 2015 Jul.

Article in En | MEDLINE | ID: mdl-25391312

Subject(s)

Carcinogenicity Tests/methods; Drug Evaluation, Preclinical/methods; Animals; Carcinogenicity Tests/standards; Drug Evaluation, Preclinical/standards; Female; Male; Maximum Tolerated Dose; Mice; Mice, Transgenic; Pathology; Retrospective Studies; Toxicology

Key words

MTD; Tg.rash2; alternative models in toxicology; carcinogenesis; preclinical research and development; toxicologic pathology

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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Carcinogenicity Tests / Drug Evaluation, Preclinical Type of study: Observational_studies / Prognostic_studies Limits: Animals Language: En Journal: Toxicol Pathol Year: 2015 Type: Article Affiliation country: United States

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