Publication Topic

Summan M, Doepker CL, Brorby GP. 2026. Safety evaluation of an aqueous root and leaf extract of Ashwagandha (Withania somnifera). Phytother Res 40(8):5030-5047; doi: 10.1002/ptr.70314. PMID: 41987003.

Bearth A, Kopainsky B, Jones LB, Vist GE, Husoy T, Svendsen C, Whaley P,…, Wikoff D, et al. 2026. Modelling the regulatory toxicology system to promote the effective use of new approach methodologies: A system thinking approach. NAM J 2(Jul 24):100120; doi: 10.1016/j.namjnl.2026.100120. PMID: 42569723

Mathisen GH, Whaley P, Kopainsky B, Ames HM, Hoffmann S, Husoy T, Jones L,…, Wikoff D, et al. 2026. Preparing for CHANGE: How systems thinking supports an effective transition from animal studies to NAMS. NAM J 2(July 20):100118; doi: 10.1016/j.namjnl.2026.100118. PMID: 42564567.

Kramer M, Torres CV. Feasibility assessment of EPA’s OEVs/ECELs. Research Roundup Presentation C1b, AIHA Connect 2026, New Orleans, LA, June 1, 2026.

Haws L (Moderator), Maxwell G (Speaker), Kleinstreuer N, Lowit A, Harrill J (Panelists). Next generation risk assessment (NGRA): Emerging best practice & opportunities for regulatory use. Society of Toxicology Risk Assessment Specialty Section (RASS) Risk Assessment Syllabus Webinar, June 17, 2026.

Wigh A, Campos B, de Croze N, Roush K, Suzuki T, Brown L, Kennedy SB, Hecker M, et al. Chronic fish toxicity case studies toward a best practice guidance document. Poster 1.09P-Mo042, SETAC Europe 36^th Annual Meeting, Maastricht, The Netherlands, May 18, 2026.

Karamertzanis PG, Rasenberg M, Shah I, Patlewicz G. 2025. Modelling in vitro mutagenicity using multi-task deep learning and REACH data. Chem Res Toxicol 38(8):1382-1407; doi: 19.1021/acs.chemrestox.5c00152. PMID: 40680271.

Mathisen GH, Bearth A, Jones LB, Hoffmann S, Vist GE, Ames HM,… Wikoff D, Wright F, Whaley P. 2024. Editorial: Time for CHANGE: System-level interventions for bringing forward the date of effective use of NAMs in regulatory toxicology. Arch Toxicol 98(8):2299-2308; doi: 10.1007/s00204-024-03802-6. PMID: 38877155.

Patlewicz G, Karamertzanis P, Paul-Friedman K, Sannicola M, Shah I. 2024. A systematic analysis of read-across within REACH registration dossiers. Comput Toxicol 30(June):100304; doi: 10.1016/j.comtox.2024.100304. PMID: 38993812.

Karamertzanis P, Patlewicz G, Sannicola M, Paul-Friedman K, Shah I. 2024. Systematic approaches for the encoding of chemical groups: A case study. Chem Res Toxicol 37(4):600-619; doi: 10.1021/acs.chemrestox.3c00411. PMID: 38498310.

Thompson CM, Proctor DM, Harris MA. 2023. Letter to “Chepelev et al. Establishing a quantitative framework for regulatory interpretation of genetic toxicity dose–response data: Margin of exposure case study of 48 compounds with both in vivo mutagenicity and carcinogenicity dose–response data.” Environ Mol Mutagen 64(4):259–260; doi: 10.1002/em.22537. PMID: 36916184.

Bartlett C, Heine L. Stay ahead of regulations and trends. ChemWatch Cosmetic Regulatory Summit, Washington, DC, October 2022.

Kimzey A, Mease K, Mounho-Zamora B, Wood M. 2021. 13. Biosimilar products—A review of past and current regulatory approval standards for preclinical safety studies. In: Translational Medicine: Optimising Preclinical Safety Evaluation of Biopharmaceuticals. CRC Press: Boca Raton, FL.

Choksi NY, Daniel AB, Allen DG, Clippinger AJ, Kleinstreuer NC. 2021. Prospective and retrospective evaluation of the eye irritation potential of agrochemical formulations. Research Triangle Park, NC: National Toxicology Program. NICEATM Report 01.

Gao R, Guan N, Huang M, Foreman J, Kung M, Rong Z, Su Y, Sweet L, et al. 2020. Read-across: Principle, case study and its potential regulatory application in China. Regul Toxicol Pharmacol 116(Oct):104728; doi: 10.1016/j.yrtph.2020.104728. PMID: 32649957.

Brinkman AM, Klaren WD, Feifarek DJ, Hillwalker W, Jones F, Zorn KM, Ekins S. Use of a weighted scheme for the interpretation and contextualization of in vitro and in silico-derived estrogenic endpoints. Poster for Society of Toxicology 59th Annual Meeting, Virtual, 2020.

Anderson J, Bartlett C, Feldmann J, Gross V, Mankin A, Lu Q, Matto K, Rosario L. An update on CDISC-SEND data submissions to FDA. Paper SA08, PHUSE US Connect 2020, Orlando, FL, March 2020.

Thompson CM. The useful chemistry of perfluorinated compounds: Managing safety. The sticky subject of non-stick: Regulatory science challenges of per- and poly-fluorinated compounds (PFAS). Texas A&M University Interdisciplinary Faculty of Toxicology Training Program, 2019 Annual Regulatory Science Symposium, College Station, TX, August 2019.

Proctor D. Use of the latest science in cancer risk assessment for hexavalent chromium: Is it time to step away from the default regulatory approaches? Invited presentation to the International Union of Toxicology (IUTOX) / International Congress of Toxicology (ICT) Meeting, Honolulu, HI, June 2019.

Choksi NY, Truax J, Layton A, Matheson J, Mattie D, Varney T, et al. 2019. United States regulatory requirements for skin and eye irritation testing. Cutan Ocul Toxicol 38(2):141–155; doi: 10.1080/15569527.2018.1540494. PMID: 30418044.