How will the genotoxicity guidelines for pharmaceuticals be changed by the ICH agreement

Report of the IWGT working group on strategy/interpretation for regulatory in vivo tests II. Identification of in vivo-only positive compounds in the bone marrow micronucleus test.

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Report of the IWGT working group on strategies and interpretation of regulatory in vivo tests I. Increases in micronucleated bone marrow cells in rodents that do not indicate genotoxic hazards.

Mutation research·2006

Region-specific chromatin decondensation and micronucleus formation induced by 5-azacytidine in human TIG-7 cells.

Cytogenetic and genome research·2004

Spindle poisons induce allelic loss in mouse lymphoma cells through mitotic non-disjunction.

Mutation research·2001

Hepatocarcinogen quinoline induces G:C to C:G transversions in the cII gene in the liver of lambda/lacZ transgenic mice (MutaMouse).

Mutation research·2000

Requirement of wild-type p53 protein for maintenance of chromosomal integrity.

Molecular carcinogenesis·2000

Synergistic protective effects of melatonin and ascorbic acid against benzene-induced genotoxicity, oxidative stress, and activin A/follistatin dysregulation in a rat model of pre-leukemia.

The Journal of toxicological sciences·2026

Consideration of the applicability domain of an in silico physiologically based pharmacokinetic model for improving the predictivity of food-related compounds.

The Journal of toxicological sciences·2026

Screening for putative epimutagens in neural stem cells derived from human induced pluripotent stem cells.

The Journal of toxicological sciences·2026

Charcoal hemoperfusion for aconite poisoning: Insights from a CKD case and complementary simulation experiments.

The Journal of toxicological sciences·2026

Lysosomal membrane permeabilization and lysosomal damage induced by silica micro/nanoparticles in murine RAW-Blue macrophages.

The Journal of toxicological sciences·2026

Linalool inhalation‒induced anxiety-like effects occur independently of olfactory input and require cytochrome P450 activity.

The Journal of toxicological sciences·2026

Risk of Schizophrenia Spectrum Disorders Following Parkinson's Disease: A Nationwide Population-Based Cohort Study.

Psychiatry investigation·2026

Breaking the 1% unbound threshold: an IQ consortium whitepaper on the evaluation of plasma protein binding of highly bound compounds.

Drug metabolism and disposition: the biological fate of chemicals·2026

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Report of the IWGT working group on strategy/interpretation for regulatory in vivo tests II. Identification of in vivo-only positive compounds in the bone marrow micronucleus test.

Report of the IWGT working group on strategies and interpretation of regulatory in vivo tests I. Increases in micronucleated bone marrow cells in rodents that do not indicate genotoxic hazards.

Region-specific chromatin decondensation and micronucleus formation induced by 5-azacytidine in human TIG-7 cells.

Spindle poisons induce allelic loss in mouse lymphoma cells through mitotic non-disjunction.

Hepatocarcinogen quinoline induces G:C to C:G transversions in the cII gene in the liver of lambda/lacZ transgenic mice (MutaMouse).

Requirement of wild-type p53 protein for maintenance of chromosomal integrity.

Synergistic protective effects of melatonin and ascorbic acid against benzene-induced genotoxicity, oxidative stress, and activin A/follistatin dysregulation in a rat model of pre-leukemia.

Consideration of the applicability domain of an in silico physiologically based pharmacokinetic model for improving the predictivity of food-related compounds.

Screening for putative epimutagens in neural stem cells derived from human induced pluripotent stem cells.

Charcoal hemoperfusion for aconite poisoning: Insights from a CKD case and complementary simulation experiments.

Lysosomal membrane permeabilization and lysosomal damage induced by silica micro/nanoparticles in murine RAW-Blue macrophages.

Linalool inhalation‒induced anxiety-like effects occur independently of olfactory input and require cytochrome P450 activity.

Risk of Schizophrenia Spectrum Disorders Following Parkinson's Disease: A Nationwide Population-Based Cohort Study.

Breaking the 1% unbound threshold: an IQ consortium whitepaper on the evaluation of plasma protein binding of highly bound compounds.

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How will the genotoxicity guidelines for pharmaceuticals be changed by the ICH agreement

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