A review of the genotoxicity of marketed pharmaceuticals

A roadmap for the development of alternative (non-animal) methods for systemic toxicity testing

“…When genotoxicity assays are combined, sensitivity inevitably increases but specificity falls: When all three tests were performed, 75-95% of non-carcinogens gave positive (i.e., false-positive) results in at least one test in the battery (Kirkland et al, 2005). For marketed drugs (which typically exclude substances found to be genotoxic during development), no particularly strong concordances were seen between the 29% positive for genotoxicity and the 38% with positive or equivocal findings in the cancer bioassay (Snyder and Green, 2001). These results raise strong questions as to whether such tests, alone or in combination, can really help to determine the carcinogenic potential of substances.…”

Antibiotic use and risk of non-Hodgkin's lymphoma: a population-based case–control study

“…The dramatic rise in antibiotic use since the 1940s has led some scientists to hypothesise that antibiotics may increase the risk of developing NHL. In vitro evidence suggests that certain antibiotics are cytotoxic (Robbana-Barnat et al, 1997;Summan and Cribb, 2002) or genotoxic (Snyder and Green, 2001), and some may have immunomodulatory effects (Van et al, 1996). Moreover, chronic infections treated with antibiotics, such as tuberculosis, have been associated with NHL (Swerdlow, 2003).…”

Impurity: Pharma Market and Importance

“…Demand for active pharmaceutical ingredients is also growing due to increase in the geriatric population globally [10].…”