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FDA no longer needs to require animal tests before human drug trials, We are an international end user assessed ethically compliant and technically competent HBS provider through Science Exchange platform
Catalogue Name :
CarcinogenSAFE
Cell Type/ Tissue:
Transchymal-UC

In Stock

CarcinogenSAFE:

Cell type used as testing platform
Transchymal-UC: Characterized Configured Human primary, stromal progenitors
About the Test
“The term carcinogen denotes a chemical substance or a mixture of chemical substances which induce cancer or increase its incidence” (UNECE, 2004, p. 167). An alternate definition is that carcinogenic substances are ones that “induce tumors (benign or malignant), increase their incidence or malignancy, or shorten the time of tumor occurrence when they are inhaled, injected, dermally applied, or ingested” (Maurici, et al., 2005, p. 177).
Carcinogens are classified according to their mode of action as genotoxic or nongenotoxic carcinogens. Genotoxic carcinogens initiate carcinogenesis by direct interaction with DNA, resulting in DNA damage or chromosomal aberrations that can be detected by genotoxicity tests (OECD, 2006). Nongenotoxic carcinogens are agents that do not directly interact with DNA and are believed to enhance tumor development by affecting gene expression, signal transduction, and/or cell proliferation. In animal studies, most potent mutagens are also found to be carcinogenic (Maurici, et al., 2005, p. 177). Substances that induce tumors in animals are considered as presumed or suspected human carcinogens until convincing evidence to the contrary is presented (UNECE, 2004, p. 167).

Assay endpoints:
Genotoxicity
For predicting potential heritable germ cell damage
Mutagenicity
For predicting potential mutagen in the molecule
Tumorigenicity
For predicting potential cancer-causing property of the molecule (safety profile)

Reference:
Avila AM, Bebenek I, Bonzo JA, Bourcier T, Davis Bruno KL, Carlson DB, Dubinion J, Elayan I, Harrouk W, Lee SL, Mendrick DL, Merrill JC, Peretz J, Place E, Saulnier M, Wange RL, Yao J, Zhao D, Brown PC. An FDA/CDER perspective on nonclinical testing strategies: Classical toxicology approaches and new approach methodologies (NAMs). Regul Toxicol Pharmacol. 2020 Jul;114:104662. doi: 10.1016/j.yrtph.2020.104662. Epub 2020 Apr 20. PMID: 32325112.

Available Resources

Catalogue Name :
CarcinogenSAFE
Cell Type/ Tissue:
Transchymal-UC

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