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Naomi L. Kruhlak
Researcher at Center for Drug Evaluation and Research
Publications - 43
Citations - 1885
Naomi L. Kruhlak is an academic researcher from Center for Drug Evaluation and Research. The author has contributed to research in topics: Quantitative structure–activity relationship & Gene mutation. The author has an hindex of 26, co-authored 42 publications receiving 1628 citations.
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Journal ArticleDOI
An analysis of genetic toxicity, reproductive and developmental toxicity, and carcinogenicity data: I. Identification of carcinogens using surrogate endpoints.
TL;DR: Results revealed that carcinogenicity was well correlated with certain tests for gene mutation, in vivo clastogenicity, unscheduled DNA synthesis assay, and reprotox among 63 endpoints.
Journal ArticleDOI
In silico toxicology protocols.
Glenn J. Myatt,Ernst Ahlberg,Yumi Akahori,David Allen,Alexander Amberg,Lennart T. Anger,Aynur O. Aptula,Scott S. Auerbach,Lisa Beilke,Phillip Bellion,Romualdo Benigni,Joel P. Bercu,Ewan D. Booth,Dave Bower,Alessandro Brigo,Natalie Burden,Zoryana Cammerer,Mark T. D. Cronin,Kevin P. Cross,Laura Custer,Magdalena Dettwiler,Krista L. Dobo,Kevin A. Ford,Marie C. Fortin,Samantha E. Gad-McDonald,Nichola Gellatly,Véronique Gervais,Kyle P. Glover,Susanne Glowienke,Jacky Van Gompel,Steve Gutsell,Barry Hardy,James Harvey,Jedd Hillegass,Masamitsu Honma,Jui-Hua Hsieh,Chia Wen Hsu,K. Hughes,Candice Y. Johnson,Robert A. Jolly,David Jones,Ray Kemper,Michelle O. Kenyon,Marlene T. Kim,Naomi L. Kruhlak,Sunil Kulkarni,Klaus Kümmerer,Penny Leavitt,Bernhard Majer,Scott A. Masten,Scott Miller,Janet Moser,Moiz Mumtaz,Wolfgang Muster,Louise Neilson,Tudor I. Oprea,Grace Patlewicz,Alexandre Paulino,Elena Lo Piparo,Mark Powley,Donald P. Quigley,M. Vijayaraj Reddy,Andrea Richarz,Patricia Ruiz,Benoît Schilter,Rositsa Serafimova,Wendy Simpson,Lidiya Stavitskaya,Reinhard Stidl,Diana Suarez-Rodriguez,David T. Szabo,Andrew Teasdale,Alejandra Trejo-Martin,Jean Pierre Valentin,Anna Vuorinen,Brian A. Wall,Pete Watts,Angela White,Joerg Wichard,Kristine L. Witt,Adam Woolley,David Woolley,Craig Zwickl,Catrin Hasselgren +83 more
TL;DR: The publication presents a novel approach for determining the reliability of in silico predictions alongside experimental data and discusses how to determine the level of confidence in the assessment based on the relevance and reliability of the information.
Journal ArticleDOI
An analysis of genetic toxicity, reproductive and developmental toxicity, and carcinogenicity data: II. Identification of genotoxicants, reprotoxicants, and carcinogens using in silico methods.
TL;DR: A novel method to identify carcinogens that employed expanded data sets composed of in silico data pooled with actual experimental genetic toxicity and reproductive and developmental toxicity data showed good correlation with carcinogenicity testing results and had correlation indicator values of 75.5-88.7%.
Journal ArticleDOI
Progress in QSAR toxicity screening of pharmaceutical impurities and other FDA regulated products.
TL;DR: Some of the considerations when using computational toxicology methods for regulatory decision support are discussed and examples of how the technology is currently being applied at the US Food and Drug Administration are given.
Journal ArticleDOI
Assessment of the Health Effects of Chemicals in Humans: I. QSAR Estimation of the Maximum Recommended Therapeutic Dose (MRTD) and No Effect Level (NOEL) of Organic Chemicals Based on Clinical Trial Data1
TL;DR: A QSAR model to estimate the no effect level (NOEL) of chemicals in humans using data derived from pharmaceutical clinical trials and the MCASE software program showed good coverage and predictions for high- and low-toxicity chemicals were good, and experimental factors which influence the accuracy of test chemical predictions were discussed.