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Practical and Science-Based Strategy for Establishing Acceptable Intakes for Drug Product N‑Nitrosamine Impurities

Chemical research in toxicology, 2022-03, Vol.35 (3), p.475-489

2022

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Strategies for Assessing Acceptable Intakes for Novel N‑Nitrosamines Derived from Active Pharmaceutical Ingredients

Journal of medicinal chemistry, 2022-12, Vol.65 (23), p.15584-15607

2022

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Evaluation of the in vivo mutagenicity of isopropyl methanesulfonate in acute and 28-day studies

Environmental and molecular mutagenesis, 2015-04, Vol.56 (3), p.322-332

2015

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A Case to Support the Continued Use of Rifampin in Clinical Drug–Drug Interaction Studies

Clinical pharmacology and therapeutics, 2024-07, Vol.116 (1), p.34-37

2024

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Development and validation of an in vitro micronucleus assay platform in TK6 cells

Mutation research, 2012-07, Vol.746 (1), p.29-34

2012

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Mechanisms of Nitrosamine Mutagenicity and Their Relationship to Rodent Carcinogenic Potency

Chemical research in toxicology, 2024-02, Vol.37 (2), p.181-198

2024

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A Strategy for the Risk Assessment of Human Genotoxic Metabolites

Chemical research in toxicology, 2009-02, Vol.22 (2), p.348-356

2009

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2‐Hydroxypyridine N‐Oxide is not genotoxic in vivo

Environmental and molecular mutagenesis, 2019-08, Vol.60 (7), p.588-593

2019

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Establishing best practise in the application of expert review of mutagenicity under ICH M7

Regulatory toxicology and pharmacology, 2015-10, Vol.73 (1), p.367-377

2015

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An evaluation of the sensitivity of the Ames assay to discern low-level mutagenic impurities

Regulatory toxicology and pharmacology, 2007-06, Vol.48 (1), p.75-86

2007

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A practical application of two in silico systems for identification of potentially mutagenic impurities

Regulatory toxicology and pharmacology, 2015-07, Vol.72 (2), p.335-349

2015

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Use of in silico systems and expert knowledge for structure-based assessment of potentially mutagenic impurities

Regulatory toxicology and pharmacology, 2013-10, Vol.67 (1), p.39-52

2013

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Deriving Compound-Specific Exposure Limits for Chemicals Used in Pharmaceutical Synthesis: Challenges in Expert Decision-Making Exemplified Through a Case Study-Based Workshop

International journal of toxicology, 2021-05, Vol.40 (3), p.285-298

2021

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2‐Hydroxypyridine‐N‐oxide (HOPO): Equivocal in the ames assay

Environmental and molecular mutagenesis, 2018-05, Vol.59 (4), p.312-321

2018

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In silico methods combined with expert knowledge rule out mutagenic potential of pharmaceutical impurities: An industry survey

Regulatory toxicology and pharmacology, 2012-04, Vol.62 (3), p.449-455

2012

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In Vivo Mutagenicity Testing of Arylboronic Acids and Esters

Environmental and molecular mutagenesis, 2019-12, Vol.60 (9), p.766-777

2019

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Resolution of contradiction between in silico predictions and Ames test results for four pharmaceutically relevant impurities

Regulatory toxicology and pharmacology, 2017-12, Vol.91, p.68-76

2017

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Defining EMS and ENU dose–response relationships using the Pig-a mutation assay in rats

Mutation research, 2011-10, Vol.725 (1-2), p.13-21

2011

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Compensatory erythropoiesis has no impact on the outcome of the in vivo Pig-a mutation assay in rats following treatment with the haemolytic agent 2-butoxyethanol

Mutagenesis, 2015-05, Vol.30 (3), p.325-334

2015

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The application of structure-based assessment to support safety and chemistry diligence to manage genotoxic impurities in active pharmaceutical ingredients during drug development

Regulatory toxicology and pharmacology, 2006-04, Vol.44 (3), p.282-293

2006

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Impact of cell cycle delay on micronucleus frequency in TK6 cells

Environmental and molecular mutagenesis, 2014-01, Vol.55 (1), p.64-69

2014

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Report on stage III Pig-a mutation assays using N-ethyl-N-nitrosourea - comparison with other in vivo genotoxicity endpoints

Environmental and molecular mutagenesis, 2011-12, Vol.52 (9), p.721-730

2011

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Evaluation of the Pig-a, micronucleus, and comet assay endpoints in a 28-day study with ethyl methanesulfonate

Environmental and molecular mutagenesis, 2014-07, Vol.55 (6), p.492-499

2014

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Comparison of metabolite profiles generated in Aroclor-induced rat liver and human liver subcellular fractions: Considerations for in vitro genotoxicity hazard assessment

Environmental and molecular mutagenesis, 2008-10, Vol.49 (8), p.631-641

2008

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Overview of Genotoxic Impurities in Pharmaceutical Development

International Journal of Toxicology, 2009-11, Vol.28 (6), p.468-478

2009

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Practical and Science-Based Strategy for Establishing Acceptable Intakes for Drug Product N‑Nitrosamine Impurities

Strategies for Assessing Acceptable Intakes for Novel N‑Nitrosamines Derived from Active Pharmaceutical Ingredients

Evaluation of the in vivo mutagenicity of isopropyl methanesulfonate in acute and 28-day studies

A Case to Support the Continued Use of Rifampin in Clinical Drug–Drug Interaction Studies

Development and validation of an in vitro micronucleus assay platform in TK6 cells

Mechanisms of Nitrosamine Mutagenicity and Their Relationship to Rodent Carcinogenic Potency

A Strategy for the Risk Assessment of Human Genotoxic Metabolites

2‐Hydroxypyridine N‐Oxide is not genotoxic in vivo

Establishing best practise in the application of expert review of mutagenicity under ICH M7

An evaluation of the sensitivity of the Ames assay to discern low-level mutagenic impurities

A practical application of two in silico systems for identification of potentially mutagenic impurities

Use of in silico systems and expert knowledge for structure-based assessment of potentially mutagenic impurities

Deriving Compound-Specific Exposure Limits for Chemicals Used in Pharmaceutical Synthesis: Challenges in Expert Decision-Making Exemplified Through a Case Study-Based Workshop

2‐Hydroxypyridine‐N‐oxide (HOPO): Equivocal in the ames assay

In silico methods combined with expert knowledge rule out mutagenic potential of pharmaceutical impurities: An industry survey

In Vivo Mutagenicity Testing of Arylboronic Acids and Esters

Resolution of contradiction between in silico predictions and Ames test results for four pharmaceutically relevant impurities

Defining EMS and ENU dose–response relationships using the Pig-a mutation assay in rats

Compensatory erythropoiesis has no impact on the outcome of the in vivo Pig-a mutation assay in rats following treatment with the haemolytic agent 2-butoxyethanol

The application of structure-based assessment to support safety and chemistry diligence to manage genotoxic impurities in active pharmaceutical ingredients during drug development

Impact of cell cycle delay on micronucleus frequency in TK6 cells

Report on stage III Pig-a mutation assays using N-ethyl-N-nitrosourea - comparison with other in vivo genotoxicity endpoints

Evaluation of the Pig-a, micronucleus, and comet assay endpoints in a 28-day study with ethyl methanesulfonate

Comparison of metabolite profiles generated in Aroclor-induced rat liver and human liver subcellular fractions: Considerations for in vitro genotoxicity hazard assessment

Overview of Genotoxic Impurities in Pharmaceutical Development

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