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Strategies for de-risking n-nitrosamine impurities in APIS

Drug metabolism and pharmacokinetics, 2024-04, Vol.55, p.100581, Article 100581

Bercu, Joel

2024

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Comparison of the transgenic rodent mutation assay, error corrected next generation duplex sequencing, and the alkaline comet assay to detect dose-related mutations following exposure to N-nitrosodiethylamine

Mutation research. Genetic toxicology and environmental mutagenesis, 2023-10, Vol.891, p.503685-503685, Article 503685

2023

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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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Use of the bacterial reverse mutation assay to predict carcinogenicity of N-nitrosamines

Regulatory toxicology and pharmacology, 2022-11, Vol.135, p.105247-105247, Article 105247

2022

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Use of less-than-lifetime (LTL) durational limits for nitrosamines: Case study of N-Nitrosodiethylamine (NDEA)

Regulatory toxicology and pharmacology, 2021-07, Vol.123, p.104926, Article 104926

2021

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An Evaluation of the Occupational Health Hazards of Peptide Couplers

Chemical research in toxicology, 2022-06, Vol.35 (6), p.1011-1022

2022

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Acceptable intakes (AIs) for 11 small molecule N-nitrosamines (NAs)

Regulatory toxicology and pharmacology, 2023-08, Vol.142, p.105415-105415, Article 105415

2023

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Harmonized 3Rs-based non-mutagenic impurity qualification study designs developed using the results of an IQ consortium survey

Regulatory toxicology and pharmacology, 2021-06, Vol.122, p.104895, Article 104895

2021

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Point of departure (PoD) selection for the derivation of acceptable daily exposures (ADEs) for active pharmaceutical ingredients (APIs)

Regulatory toxicology and pharmacology, 2016-08, Vol.79, p.S48-S56

2016

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Qualification of impurities based on metabolite data

Regulatory toxicology and pharmacology, 2020-02, Vol.110, p.104524, Article 104524

2020

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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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Threshold of toxicological concern (TTC) for developmental and reproductive toxicity of anticancer compounds

Regulatory toxicology and pharmacology, 2015-08, Vol.72 (3), p.602-609

2015

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Using default methodologies to derive an acceptable daily exposure (ADE)

Regulatory toxicology and pharmacology, 2016-08, Vol.79, p.S28-S38

2016

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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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Advancing toxicology in RiskMAPP: Setting ADEs based on the subsequent drug substance

Regulatory toxicology and pharmacology, 2013-02, Vol.65 (1), p.157-161

2013

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Application of the threshold of toxicological concern concept when applied to pharmaceutical manufacturing operations intended for short-term clinical trials

Regulatory toxicology and pharmacology, 2013-02, Vol.65 (1), p.162-167

2013

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Toxicogenomics and cancer risk assessment: A framework for key event analysis and dose–response assessment for nongenotoxic carcinogens

Regulatory toxicology and pharmacology, 2010-12, Vol.58 (3), p.369-381

2010

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A harmonization effort for acceptable daily exposure application to pharmaceutical manufacturing – Operational considerations

Regulatory toxicology and pharmacology, 2016-08, Vol.79, p.S39-S47

2016

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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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Risk Assessment of Genotoxic Impurities in Marketed Compounds Administered over a Short-Term Duration: Applications to Oncology Products and Implications for Impurity Control Limits

Organic process research & development, 2010-07, Vol.14 (4), p.986-992

2010

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A proposed framework for assessing risk from less-than-lifetime exposures to carcinogens

Critical reviews in toxicology, 2011-07, Vol.41 (6), p.507-544

2011

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In silico approaches to predicting cancer potency for risk assessment of genotoxic impurities in drug substances

Regulatory toxicology and pharmacology, 2010-07, Vol.57 (2-3), p.300-306

2010

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Human health risk assessments for three neuropharmaceutical compounds in surface waters

Regulatory toxicology and pharmacology, 2008-04, Vol.50 (3), p.420-427

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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Quantitative assessment of cumulative carcinogenic risk for multiple genotoxic impurities in a new drug substance

Regulatory toxicology and pharmacology, 2008-08, Vol.51 (3), p.270-277

2008

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Strategies for de-risking n-nitrosamine impurities in APIS

Comparison of the transgenic rodent mutation assay, error corrected next generation duplex sequencing, and the alkaline comet assay to detect dose-related mutations following exposure to N-nitrosodiethylamine

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

Use of the bacterial reverse mutation assay to predict carcinogenicity of N-nitrosamines

Use of less-than-lifetime (LTL) durational limits for nitrosamines: Case study of N-Nitrosodiethylamine (NDEA)

An Evaluation of the Occupational Health Hazards of Peptide Couplers

Acceptable intakes (AIs) for 11 small molecule N-nitrosamines (NAs)

Harmonized 3Rs-based non-mutagenic impurity qualification study designs developed using the results of an IQ consortium survey

Point of departure (PoD) selection for the derivation of acceptable daily exposures (ADEs) for active pharmaceutical ingredients (APIs)

Qualification of impurities based on metabolite data

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

Threshold of toxicological concern (TTC) for developmental and reproductive toxicity of anticancer compounds

Using default methodologies to derive an acceptable daily exposure (ADE)

In Vivo Mutagenicity Testing of Arylboronic Acids and Esters

Advancing toxicology in RiskMAPP: Setting ADEs based on the subsequent drug substance

Application of the threshold of toxicological concern concept when applied to pharmaceutical manufacturing operations intended for short-term clinical trials

Toxicogenomics and cancer risk assessment: A framework for key event analysis and dose–response assessment for nongenotoxic carcinogens

A harmonization effort for acceptable daily exposure application to pharmaceutical manufacturing – Operational considerations

A Strategy for the Risk Assessment of Human Genotoxic Metabolites

Risk Assessment of Genotoxic Impurities in Marketed Compounds Administered over a Short-Term Duration: Applications to Oncology Products and Implications for Impurity Control Limits

A proposed framework for assessing risk from less-than-lifetime exposures to carcinogens

In silico approaches to predicting cancer potency for risk assessment of genotoxic impurities in drug substances

Human health risk assessments for three neuropharmaceutical compounds in surface waters

Overview of Genotoxic Impurities in Pharmaceutical Development

Quantitative assessment of cumulative carcinogenic risk for multiple genotoxic impurities in a new drug substance

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