Naomi L. Kruhlak

United States Food and Drug Administration — United States

Computer Science · Physical Sciences

31h-index2.5kcitations58works39.52yr avg
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Research Topics

Computational Drug Discovery Methods(30), Carcinogens and Genotoxicity Assessment(21), Pharmacogenetics and Drug Metabolism(8), Effects and risks of endocrine disrupting chemicals(6), Metabolomics and Mass Spectrometry Studies(6)

Publications58 total

Optimizing the detection of N-nitrosamine mutagenicity in the Ames test
Regulatory Toxicology and Pharmacology·2024· 23 citedOpen Access
Determining recommended acceptable intake limits for N-nitrosamine impurities in pharmaceuticals: Development and application of the Carcinogenic Potency Categorization Approach (CPCA)
Regulatory Toxicology and Pharmacology·2024· 56 citedOpen Access
New science, drug regulation, and emergent public health issues: The work of FDA’s division of applied regulatory science
Frontiers in Medicine·2023· 23 citedOpen Access
In silico approaches in carcinogenicity hazard assessment: Current status and future needs
Computational Toxicology·2021· 40 citedOpen Access
Assessing the impact of expert knowledge on ICH M7 (Q)SAR predictions. Is expert review still needed?
Regulatory Toxicology and Pharmacology·2021· 20 citedOpen Access
Management of pharmaceutical ICH M7 (Q)SAR predictions – The impact of model updates
Regulatory Toxicology and Pharmacology·2020· 31 citedOpen Access
Evaluating kratom alkaloids using PHASE
PLoS ONE·2020· 54 citedOpen Access
Development of improved QSAR models for predicting the outcome of the in vivo micronucleus genetic toxicity assay
Regulatory Toxicology and Pharmacology·2020· 20 citedOpen Access
Transitioning to composite bacterial mutagenicity models in ICH M7 (Q)SAR analyses
Regulatory Toxicology and Pharmacology·2019· 32 citedOpen Access
Genetic toxicology in silico protocol
Regulatory Toxicology and Pharmacology·2019· 78 citedOpen Access
Assessing the Structural and Pharmacological Similarity of Newly Identified Drugs of Abuse to Controlled Substances Using Public Health Assessment via Structural Evaluation
Clinical Pharmacology & Therapeutics·2019· 21 citedOpen Access
Principles and procedures for handling out-of-domain and indeterminate results as part of ICH M7 recommended (Q)SAR analyses
Regulatory Toxicology and Pharmacology·2018· 31 citedOpen Access
Construction and application of (Q)SAR models to predict chemical-induced in vitro chromosome aberrations
Regulatory Toxicology and Pharmacology·2018· 10 citedOpen Access
Extending (Q)SARs to incorporate proprietary knowledge for regulatory purposes: is aromatic<i>N</i>-oxide a structural alert for predicting DNA-reactive mutagenicity?*
Mutagenesis·2018· 17 citedOpen Access
Predicting opioid receptor binding affinity of pharmacologically unclassified designer substances using molecular docking
PLoS ONE·2018· 81 citedOpen Access
In silico toxicology protocols
Regulatory Toxicology and Pharmacology·2018· 234 citedOpen Access
Translating New Science Into the Drug Review Process: The US FDA’s Division of Applied Regulatory Science
Therapeutic Innovation & Regulatory Science·2017· 35 citedOpen Access
Extending (Q)SARs to incorporate proprietary knowledge for regulatory purposes: A case study using aromatic amine mutagenicity
Regulatory Toxicology and Pharmacology·2016· 45 cited
Principles and procedures for implementation of ICH M7 recommended (Q)SAR analyses
Regulatory Toxicology and Pharmacology·2016· 108 citedOpen Access
Establishing best practise in the application of expert review of mutagenicity under ICH M7
Regulatory Toxicology and Pharmacology·2015· 81 cited
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Frequent Co-authors

Lidiya Stavitskaya(17), R. Benz(17), Joseph F. Contrera(17), Edwin J. Matthews(16), Kevin P. Cross(11), Glenn J. Myatt(8), Alexander Amberg(8), Angela White(8), Laura Custer(7), Masamitsu Honma(7), Michelle Kenyon(7), Andrew Teasdale(7), Joerg Wichard(7), Catrin Hasselgren(7), Joel P. Bercu(6), Krista L. Dobo(6), Susanne Glowienke(6), Jacky Van Gompel(6), James Harvey(6), Robert A. Jolly(6)