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N-Nitrosamine Formation in Pharmaceutical Solid Drug Products: Experimental Observations

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Error-corrected next-generation sequencing to advance nonclinical genotoxicity and carcinogenicity testing

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Enhancing global and local decision making for chemical safety assessments through increasing the availability of data

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Quantum-Mechanical Approach to Predicting the Carcinogenic Potency of N-Nitroso Impurities in Pharmaceuticals

(2023) Jakub Kostal et al.   Chemical Research in Toxicology

A Consideration of the Extent That Tertiary Amines Can Form N-Nitroso Dialkylamines in Pharmaceutical Products

(2023) Ian W. Ashworth et al.   Organic Process Research & Development

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Drawing a Line: Where Might the Cohort of Concern End?

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Risk assessment for nitrosated pharmaceuticals: A future perspective in drug development

(2022) Sebastian Schmidtsdorff et al.   ARCHIV DER PHARMAZIE

Salmonella typhimurium TA100 and TA1535 and E. coli WP2 uvrA are highly sensitive to detect the mutagenicity of short Alkyl-N-Nitrosamines in the Bacterial Reverse Mutation Test

(2022) Frank Bringezu et al.   Toxicology Reports

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

(2022) Krista L. Dobo et al.   CHEMICAL RESEARCH IN TOXICOLOGY

A Nitrite Excipient Database: A useful Tool to Support N-Nitrosamine Risk Assessments for Drug Products

(2022) Ruth Boetzel et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Letter to the editor of Heliyon re: determination of dimethylamine and nitrite in pharmaceuticals by ion chromatography to assess the likelihood of nitrosamine formation Heliyon. 2021; 77: e06179

(2022) Joerg Schlingemann et al.   Heliyon

What Makes a Potent Nitrosamine? Statistical Validation of Expert-Derived Structure–Activity Relationships

(2022) Robert Thomas et al.   CHEMICAL RESEARCH IN TOXICOLOGY

Predicting DNA-Reactivity of N-Nitrosamines: A Quantum Chemical Approach

(2022) Jan Wenzel et al.   CHEMICAL RESEARCH IN TOXICOLOGY

Trace Aldehydes in Solid Oral Dosage Forms as Catalysts for Nitrosating Secondary Amines

(2022) Paul Harmon   JOURNAL OF PHARMACEUTICAL SCIENCES

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

(2022) Alejandra Trejo-Martin et al.   REGULATORY TOXICOLOGY AND PHARMACOLOGY

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

(2022) David J. Ponting et al.   Journal of Medicinal Chemistry

The Landscape of Potential Small and Drug Substance Related Nitrosamines in Pharmaceuticals

(2022) Joerg Schlingemann et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

A matched molecular pair (MMP) approach for selecting analogs suitable for structure activity relationship (SAR)-based read across

(2021) Cathy C. Lester et al.   REGULATORY TOXICOLOGY AND PHARMACOLOGY

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

(2021) Joel P. Bercu et al.   REGULATORY TOXICOLOGY AND PHARMACOLOGY

Developing Structure-Activity Relationships for N-Nitrosamine Activity

(2021) Kevin P. Cross et al.   Computational Toxicology

Predicting pKa Using a Combination of Semi-Empirical Quantum Mechanics and Radial Basis Function Methods

(2020) Peter Hunt et al.   Journal of Chemical Information and Modeling

Potential for the Formation of N-Nitrosamines During the Manufacture of Active Pharmaceutical Ingredients: An Assessment of the Risk Posed by Trace Nitrite in Water

(2020) Ian W. Ashworth et al.   ORGANIC PROCESS RESEARCH & DEVELOPMENT

Are all nitrosamines concerning? A review of mutagenicity and carcinogenicity data

(2020) Andrew Thresher et al.   REGULATORY TOXICOLOGY AND PHARMACOLOGY

Investigation of the Inhibition of Eight Major Human Cytochrome P450 Isozymes by a Probe Substrate Cocktail in vitro with Emphasis on CYP2E1

(2019) Guru R. Valicherla et al.   XENOBIOTICA

Critical review of major sources of human exposure to N -nitrosamines

(2018) Adam J. Gushgari et al.   CHEMOSPHERE

Is preclinical data sharing the new norm?

(2018) Katharine A. Briggs   DRUG DISCOVERY TODAY

JPlogP: an improved logP predictor trained using predicted data

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Quantifying the benefits of using read-across and in silico techniques to fulfill hazard data requirements for chemical categories

(2016) Kathleen Stanton et al.   REGULATORY TOXICOLOGY AND PHARMACOLOGY

Drinking Water as a Proportion of Total Human Exposure to VolatileN-Nitrosamines

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

(2011) Susan P. Felter et al.   CRITICAL REVIEWS IN TOXICOLOGY

Generation of a Set of Simple, Interpretable ADMET Rules of Thumb

(2008) M. Paul Gleeson   JOURNAL OF MEDICINAL CHEMISTRY

In Silico Tools for Sharing Data and Knowledge on Toxicity and Metabolism: Derek for Windows, Meteor, and Vitic

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