Non‐neoplastic lesions found only in the two‐year bioassays but not in shorter toxicity studies of rats
Sign Up to like & getrecommendations! Published in 2017 at "Regulatory Toxicology and Pharmacology"
DOI: 10.1016/j.yrtph.2017.03.008
Abstract: &NA; International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has been conducting a prospective evaluation period to validate the criteria for waiving some carcinogenicity studies in rats. Before… read more here.
Keywords: year; carcinogenicity studies; toxicity; neoplastic lesions ... See more keywords
A Collaborative Initiative to Establish Genomic Biomarkers for Assessing Tumorigenic Potential to Reduce Reliance on Conventional Rodent Carcinogenicity Studies
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DOI: 10.1093/toxsci/kfac041
Abstract: Abstract There is growing recognition across broad sectors of the scientific community that use of genomic biomarkers has the potential to reduce the need for conventional rodent carcinogenicity studies of industrial chemicals, agrochemicals, and pharmaceuticals… read more here.
Keywords: carcinogenicity; rodent carcinogenicity; rodent; potential reduce ... See more keywords
The Antitussive Benzonatate Is Not Tumorigenic in Rodent Carcinogenicity Studies
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DOI: 10.1177/0192623318789130
Abstract: Benzonatate is a peripheral oral antitussive that dampens the activity of cough stretch receptors. Rodent carcinogenicity studies were performed in Tg.rasH2 mice and Wistar Han rats. Mice were orally gavaged benzonatate at 10, 30, 75,… read more here.
Keywords: carcinogenicity studies; day; benzonatate; rodent carcinogenicity ... See more keywords
Tg.rasH2 Mice and not CByB6F1 Mice Should Be Used for 28-Day Dose Range Finding Studies Prior to 26-Week Tg.rasH2 Carcinogenicity Studies
Sign Up to like & getrecommendations! Published in 2017 at "International Journal of Toxicology"
DOI: 10.1177/1091581817707458
Abstract: Our recent retrospective analysis of data, collected from 29 Tg.rasH2 mouse carcinogenicity studies, determined how successful the strategy of choosing the high dose for the 26-week studies was based on the estimated maximum tolerated dose… read more here.
Keywords: rash2 mice; cbyb6f1 mice; week; carcinogenicity studies ... See more keywords