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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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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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Quantum-Mechanics Calculations Elucidate Skin-Sensitizing Pharmaceutical Compounds

Chemical research in toxicology, 2024-08, Vol.37 (8), p.1404-1414

2024

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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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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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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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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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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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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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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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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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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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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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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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In Silico Assessment of Biomolecule Reactivity with Leachables

PDA journal of pharmaceutical science and technology, 2024-06, Vol.78 (3), p.214-236

2024

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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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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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Development of Duration-Based Non-Mutagenic Thresholds of Toxicological Concern (TTCs) Relevant to Parenteral Extractables and Leachables (E&Ls)

PDA journal of pharmaceutical science and technology, 2022-09, Vol.76 (5), p.369-383

2022

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

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

Quantum-Mechanics Calculations Elucidate Skin-Sensitizing Pharmaceutical Compounds

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

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

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

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

A Strategy for the Risk Assessment of Human Genotoxic Metabolites

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

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

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

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

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

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

In Silico Assessment of Biomolecule Reactivity with Leachables

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

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

In Vivo Mutagenicity Testing of Arylboronic Acids and Esters

Development of Duration-Based Non-Mutagenic Thresholds of Toxicological Concern (TTCs) Relevant to Parenteral Extractables and Leachables (E&Ls)

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

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

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

Human health risk assessments for three neuropharmaceutical compounds in surface waters

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