Genotoxic
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ICH guideline M7 on assessment and control of DNA reactive ...
www.ema.europa.euNo. The terms “mutagenic potential” and “genotoxic potential” are not interchangeable. Mutagenic potential refers to the ability of a compound to induce point mutations (i.e., bacterial reverse mutation assay), while genotoxic potential refers to both mutagenic and clastogenic potential. ICH M7 focuses specifically on
N-Nitrosodimethylamine (NDMA) - World Health …
www.who.intThere is also ample evidence that NDMA is genotoxic both in vivo and in vitro. Activation by liver microsomal S9 fractions is necessary for a positive in vitro result. The recent observation that human S9 fractions are much more active in promoting genotoxicity in the Ames test than rat S9 fractions suggests that humans may be especially ...
A C DNA R (M P L P C R M7(R1) - ICH
database.ich.orgsome cases where a drug substance intended for other indications is itself genotoxic at therapeutic concentrations and may be expected to be associated with an increased cancer risk. Exposure to a mutagenic impurity in these cases would not significantly add to the
Table of Genetic Disorders - Loyola University Chicago
www.meddean.luc.eduenvironmental genotoxic agents. Title: Microsoft Word - Table of Genetic Disorders.doc Author: afrankf Created Date: 4/21/2005 9:59:39 PM ...
Genotoxic Impurities and Its Risk Assessment in Drug …
lupinepublishers.comGenotoxic impurities can get incorporated into drug substances through the various sources, the major source is the starting material used in the synthesis of drug substances and its impurities. Similarly, genotoxic intermediate and by-products formed in the synthesis process may get be carried forward to the drug substances as genotoxic ...