By Jithan A.
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The same studies could be extrapolated to new chemical entities. Thus, in this regard, both single dose toxicity studies as well as multidose toxicity studies are essential. , daily versus intermittent dosing) should reflect the intended clinical use or exposure. When feasible, these studies should include toxicokinetics. A recovery period should generally be included in study designs to determine the reversal or potential worsening of pharmacological/toxicological effects, and potential delayed toxic effects.
Basically the changes are in the alterations in the genetic material. Only genetic testing will be discussed henceforth here and further tests are discussed in subsequent sections of this chapter and could also be referred in literature. Genetic testing focuses on a new drug to cause mutations (in single-cell systems) or other forms of genetic damage. Ames test is the most common test used to evaluate 40 Oral Drug Delivery Technology the mutagenic potential of a new chemical entity. In vitro mouse micronucleus test is used to determine the chromosal damage.
The other mutagenic test that is used include Ames Salmonella reversion assay and is not discussed here. In the construction of the softwares MCASE, TOPKAT and DEREK, the genetic toxicology findings of several new chemical entities was extracted from the 2000-2002 Physicians' Desk Reference and evaluated using MCASE, TOPKAT, and DEREK. 9%). , the so-called Ashby alerts; 61 % ± 14% sensitivity) than for those without such alerts (12% ± 6% sensitivity). Taking all genotoxicity assay findings into consideration, there were 84 instances in which positive genotoxicity results could not be explained in terms of structural alerts, suggesting the possibility of alternative mechanisms of genotoxicity not relating to covalent drug-DNA interaction.