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.

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.

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.

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.