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Considerations for the genotoxicity assessment of middle size peptide drugs containing non-canonical amino acid residues

Genes and environment, 2023-12, Vol.45 (1), p.36-36, Article 36

2023

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Preclinical in vitro evaluation of immune suppression induced by GYM329, Fc-engineered sweeping antibody

The Journal of Toxicological Sciences, 2023, Vol.48(7), pp.399-409

2023

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Derivation of the permitted daily exposure value for p-tert-butylphenol as an impurity in pharmaceutical products

Fundamental toxicological sciences, 2023, Vol.10 (7), p.301-306

2023

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Rapid in vitro assessment of the immunogenicity potential of engineered antibody therapeutics through detection of CD4 + T cell interleukin-2 secretion

mAbs, 2023-12, Vol.15 (1), p.2253570-2253570

2023

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Derivation of permitted daily exposure value for trifluoroacetic acid as an impurity in pharmaceutical products

Fundamental toxicological sciences, 2023, Vol.10 (7), p.307-313

2023

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Derivation of permitted daily exposure value for 1,8-diazabicyclo[5.4.0]undec-7-ene in pharmaceutical products

Fundamental toxicological sciences, 2023, Vol.10 (7), p.295-300

2023

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High-content imaging analyses of γH2AX-foci and micronuclei in TK6 cells elucidated genotoxicity of chemicals and their clastogenic/aneugenic mode of action

Genes and environment, 2019-02, Vol.41 (1), p.4-15, Article 4

2019

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Is an in vitro whole blood cytokine assay useful to detect the potential risk of severe infusion reaction of monoclonal antibody pharmaceuticals?

The Journal of Toxicological Sciences, 2016/08/01, Vol.41(4), pp.523-531

2016

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Advantages of evaluating γH2AX induction in non-clinical drug development

Genes and environment, 2018-05, Vol.40 (1), p.10-10, Article 10

2018

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Limited ability of DNA polymerase kappa to suppress benzo[a]pyrene‐induced genotoxicity in vivo

Environmental and molecular mutagenesis, 2017-12, Vol.58 (9), p.644-653

2017

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In vitro human helper T-cell assay to screen antibody drug candidates for immunogenicity

Journal of immunotoxicology, 2019-01, Vol.16 (1), p.125-132

2019

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Meeting report, ICH M7 relevant workshop: use of (Q)SAR systems and expert judgment

Genes and environment, 2018-09, Vol.40 (1), p.1-7, Article 19

2018

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Integrated approach to testing and assessment for predicting rodent genotoxic carcinogenicity

Journal of applied toxicology, 2016-12, Vol.36 (12), p.1536-1550

2016

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Chromosomal aberrations, clastogens vs aneugens

Frontiers in bioscience (Scholar edition), 2017-01, Vol.9 (1), p.1-16, Article 468

Mishima, Masayuki

2017

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Derivation of acceptable daily exposure value for alanine, N,N-bis(carboxymethyl)-, trisodium salt

Fundamental toxicological sciences, 2018-11, Vol.5 (5), p.167-170

2018

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Weight of evidence approach using a TK gene mutation assay with human TK6 cells for follow-up of positive results in Ames tests: a collaborative study by MMS/JEMS

Genes and environment, 2021-03, Vol.43 (1), p.7-19, Article 7

2021

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New DNA probes to detect aneugenicity in rat bone marrow micronucleated cells by a pan-centromeric FISH analysis

Mutation research, 2013-07, Vol.755 (1), p.73-80

2013

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Giemsa-stained pseudo-micronuclei in rat skin treated with vitamin D3 analog, pefcalcitol

Genes and environment, 2017-06, Vol.39 (1), p.17-17, Article 17

2017

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Considerations for the genotoxicity assessment of middle size peptide drugs containing non-canonical amino acid residues

Genes and Environment, 2023, Vol.45 (36), p.1-6

2023

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Priming treatment with T-cell redirecting bispecific antibody ERY974 reduced cytokine induction without losing cytotoxic activity in vitro by changing the chromatin state in T cells

Toxicology and applied pharmacology, 2022-04, Vol.441, p.115986-115986, Article 115986

2022

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Lack of Mutagenicity of SMD-502, a New Vitamin D3 Analog for Topical Application, in Skin and Liver of gpt delta Transgenic Mice and in GDL1 Cells

Genes and Environment, 2012, Vol.34(3), pp.107-114

2012

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In vitro toxicological support to establish specification limit for anti-CD3 monospecific impurity in a bispecific T cell engager drug, ERY974

Toxicology in vitro, 2020-08, Vol.66, p.104841, Article 104841

2020

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The predominant role of apoptosis in γH2AX formation induced by aneugens is useful for distinguishing aneugens from clastogens

Mutation research. Genetic toxicology and environmental mutagenesis, 2014-09, Vol.771, p.23-29

2014

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Different players generate positive responses in two in vitro cytokine assay formats with aqueous and immobilized TGN1412 analog

Biochemical and biophysical research communications, 2018-07, Vol.502 (1), p.91-97

2018

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Daily ascending dosing in cynomolgus monkeys to mitigate cytokine release syndrome induced by ERY22, surrogate for T-cell redirecting bispecific antibody ERY974 for cancer immunotherapy

Toxicology and applied pharmacology, 2019-09, Vol.379, p.114657, Article 114657

2019

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Considerations for the genotoxicity assessment of middle size peptide drugs containing non-canonical amino acid residues

Preclinical in vitro evaluation of immune suppression induced by GYM329, Fc-engineered sweeping antibody

Derivation of the permitted daily exposure value for p-tert-butylphenol as an impurity in pharmaceutical products

Rapid in vitro assessment of the immunogenicity potential of engineered antibody therapeutics through detection of CD4 + T cell interleukin-2 secretion

Derivation of permitted daily exposure value for trifluoroacetic acid as an impurity in pharmaceutical products

Derivation of permitted daily exposure value for 1,8-diazabicyclo[5.4.0]undec-7-ene in pharmaceutical products

High-content imaging analyses of γH2AX-foci and micronuclei in TK6 cells elucidated genotoxicity of chemicals and their clastogenic/aneugenic mode of action

Is an in vitro whole blood cytokine assay useful to detect the potential risk of severe infusion reaction of monoclonal antibody pharmaceuticals?

Advantages of evaluating γH2AX induction in non-clinical drug development

Limited ability of DNA polymerase kappa to suppress benzo[a]pyrene‐induced genotoxicity in vivo

In vitro human helper T-cell assay to screen antibody drug candidates for immunogenicity

Meeting report, ICH M7 relevant workshop: use of (Q)SAR systems and expert judgment

Integrated approach to testing and assessment for predicting rodent genotoxic carcinogenicity

Chromosomal aberrations, clastogens vs aneugens

Derivation of acceptable daily exposure value for alanine, N,N-bis(carboxymethyl)-, trisodium salt

Weight of evidence approach using a TK gene mutation assay with human TK6 cells for follow-up of positive results in Ames tests: a collaborative study by MMS/JEMS

New DNA probes to detect aneugenicity in rat bone marrow micronucleated cells by a pan-centromeric FISH analysis

Giemsa-stained pseudo-micronuclei in rat skin treated with vitamin D3 analog, pefcalcitol

Considerations for the genotoxicity assessment of middle size peptide drugs containing non-canonical amino acid residues

Priming treatment with T-cell redirecting bispecific antibody ERY974 reduced cytokine induction without losing cytotoxic activity in vitro by changing the chromatin state in T cells

Lack of Mutagenicity of SMD-502, a New Vitamin D3 Analog for Topical Application, in Skin and Liver of gpt delta Transgenic Mice and in GDL1 Cells

In vitro toxicological support to establish specification limit for anti-CD3 monospecific impurity in a bispecific T cell engager drug, ERY974

The predominant role of apoptosis in γH2AX formation induced by aneugens is useful for distinguishing aneugens from clastogens

Different players generate positive responses in two in vitro cytokine assay formats with aqueous and immobilized TGN1412 analog

Daily ascending dosing in cynomolgus monkeys to mitigate cytokine release syndrome induced by ERY22, surrogate for T-cell redirecting bispecific antibody ERY974 for cancer immunotherapy

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