1999
DOI: 10.1093/mutage/14.3.265
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The mouse lymphoma assay in the wake of ICH4where are we now?

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Cited by 10 publications
(4 citation statements)
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“…The standard treatment bothand + S9 were negative. The rationale for including an extended treatment time in the mouse lymphoma assay was based on information that suggested it may allow this assay to detect certain materials that were positive in the in vitro cytogenetic assay, but were negative in the standard mouse lymphoma assay (Cole et al, 1999;ICH 2011). In other words, this segment of the assay was added to try to detect materials acting at the chromosomal level rather than the gene mutation level, and ones that an IVC assay would detect.…”
Section: Discussionmentioning
confidence: 99%
“…The standard treatment bothand + S9 were negative. The rationale for including an extended treatment time in the mouse lymphoma assay was based on information that suggested it may allow this assay to detect certain materials that were positive in the in vitro cytogenetic assay, but were negative in the standard mouse lymphoma assay (Cole et al, 1999;ICH 2011). In other words, this segment of the assay was added to try to detect materials acting at the chromosomal level rather than the gene mutation level, and ones that an IVC assay would detect.…”
Section: Discussionmentioning
confidence: 99%
“…It is more usual to omit a mammalian cell gene mutation assay from the core tier 1 battery of tests, although the International Conference on Harm onisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH; 33) suggested the inclusion of such an assay, and in particular, the mouse lymphoma gene mutation assay, in the core battery of tests. This requirement was endorsed by the results of a collaborative trial, which demonstrated the equivalence of the cytogenetics and mouse lymphoma gene mutation assays for detecting the activities of a range of chemicals (see 34,35).…”
Section: In Vitro Methods -Gene Mutation (The Mouse Lymphoma Assay)mentioning
confidence: 99%
“…It is more usual to omit a mammalian cell gene mutation assay from the core tier 1 battery of tests, although the International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH; 33) suggested the inclusion of such an assay, and in particular, the mouse lymphoma gene mutation assay, in the core battery of tests. This requirement was endorsed by the results of a collaborative trial, which demonstrated the equivalence of the cytogenetics and mouse lymphoma gene mutation assays for detecting the activities of a range of chemicals (see 34,35).…”
Section: In Vitro Methods -Gene Mutation (The Mouse Lymphoma Assay)mentioning
confidence: 99%