Mutagenic impurities in pharmaceuticals: a critique of the derivation of the cancer TTC (Threshold of Toxicological Concern) and recommendations for structural-class …
DJ Snodin, SD McCrossen - Regulatory Toxicology and Pharmacology, 2013 - Elsevier
… Our evaluation challenges a number of key elements of the … carcinogenic potency data (TD
50 s in mg/kg/day, the cancer … subcutaneous injection with assessment of tumor development …
50 s in mg/kg/day, the cancer … subcutaneous injection with assessment of tumor development …
[HTML][HTML] The challenge of the application of'omics technologies in chemicals risk assessment: background and outlook
UG Sauer, L Deferme, L Gribaldo… - Regulatory Toxicology …, 2017 - Elsevier
… This survey summarizes legal, regulatory, scientific and technical challenges that have to
be met to facilitate the regulatory use of ‘omics technologies. Thereby, it serves as background …
be met to facilitate the regulatory use of ‘omics technologies. Thereby, it serves as background …
Uncertainties in human health risk assessment of environmental contaminants: a review and perspective
… cancer effect, cancer slope factors (CSF) – usually a 95% upper confidence limit – are used
to estimate the risk of cancer associated with exposure to a carcinogenic … and challenges …
to estimate the risk of cancer associated with exposure to a carcinogenic … and challenges …
Nano-TiO2 – feasibility and challenges for human health risk assessment based on open literature
… As noted previously, NIOSH assumes TiO 2 to be carcinogenic in rats following a non-…
cancer. On that basis, NIOSH will not exclude that nano/ultrafine-TiO 2 is a human carcinogen and …
cancer. On that basis, NIOSH will not exclude that nano/ultrafine-TiO 2 is a human carcinogen and …
On the application of data on mode of action to carcinogenic risk assessment
JM Rice - Toxicological Sciences, 2004 - academic.oup.com
… cancer risk assessments supports, rather than undermines, public health by focusing attention
where it belongs, on substances that are most likely to pose a carcinogenic … challenges for …
where it belongs, on substances that are most likely to pose a carcinogenic … challenges for …
Next‐generation genotoxicology: using modern sequencing technologies to assess somatic mutagenesis and cancer risk
JJ Salk, SR Kennedy - Environmental and Molecular …, 2020 - Wiley Online Library
… of a compound has become a de facto surrogate for carcinogenicity (Fig. 1). A detailed …
term “neo-genotoxins,” presents both new challenges and new opportunities for the field. A …
term “neo-genotoxins,” presents both new challenges and new opportunities for the field. A …
Derisking drug-induced carcinogenicity for novel therapeutics
JG Moggs, T MacLachlan, HJ Martus, P Bentley - Trends in Cancer, 2016 - cell.com
… Recent progress in developing advanced cell and gene therapy products is generating
new challenges for cancer risk assessment. Whilst existing genetic toxicity testing paradigms …
new challenges for cancer risk assessment. Whilst existing genetic toxicity testing paradigms …
Glyphosate toxicity and carcinogenicity: a review of the scientific basis of the European Union assessment and its differences with IARC
JV Tarazona, D Court-Marques, M Tiramani… - Archives of …, 2017 - Springer
… assessment conducted within the European Union (EU) renewal process, and explains the
differences in the carcinogenicity assessment … between exposure and cancer incidences are …
differences in the carcinogenicity assessment … between exposure and cancer incidences are …
Biomarkers of carcinogenicity and their roles in drug discovery and development
P Guan, A Olaharski, M Fielden, N Roome… - Expert Review of …, 2008 - Taylor & Francis
… the challenges of … carcinogenic activity of many nongenotoxic agents can have species,
strain and tissue specificity, and their relevance to human cancer risk needs to be assessed …
strain and tissue specificity, and their relevance to human cancer risk needs to be assessed …
IARC monographs: 40 years of evaluating carcinogenic hazards to humans
… on Cancer (IARC) are a prominent example of such an expert review process. The goal of
the Monograph Programme is to assess carcinogenic … poses special challenges to scientific …
the Monograph Programme is to assess carcinogenic … poses special challenges to scientific …