Publications

Mihalchik AL. TTC in context: Comparing the pharmaceutical TTC with other regulatory sectors. Poster OR-09, Oral Session 3, American Society for Cellular and Computational Toxicology (ASCCT) 15^th Annual Meeting, Durham, NC, October 28, 2026.

Patlewicz G, Mihalchik AL. Refinement of the threshold of toxicological concern (TTC): A computational framework for cross-scheme comparison of TTC values. Poster 24, Poster Session 1, American Society for Cellular and Computational Toxicology (ASCCT) 15^th Annual Meeting, Durham, NC, October 27, 2026.

Mihalchik AL, Roberts A, LaCombe J, Lloyd M, Doepker C, Eapen A. 2026. Evaluation of the safety and potential genotoxicity of a high-purity mogroside ingredient containing siamenoside I produced from a modified strain of Yarrowia lipolytica. Toxicol Rep 17(Dec):102297; doi: 10.1016/j.toxrep.2026.102297. PMID: 42388455.

Patlewicz GY, Mihalchik AL. 2026. Revisiting the Threshold of Toxicological Concern: A computational framework for structural classification, cross-scheme comparison and opportunities for refinement. Comput Toxicol 39(Sept):100443; doi: 10.1016/j.comtox.2026.100443.

Patlewicz GY, Mihalchik AL, East A, Borghoff SJ, Thompson CM. 2026. Investigating the feasibility of deriving new environmentally relevant thresholds of Toxicological Concern (TTCs) from estimated chronic human equivalent benchmark dose (eBMD_HED) values. Comput Toxicol 38(June):100417; doi: 10.1016/j.comtox.2026.100417.

Patlewicz G, Mihalchik A, Thompson CM, East A, Borghoff S. Investigating the feasibility of deriving a new environmentally relevant Thresholds of Toxicological Concern (TTCs) from estimated human equivalent benchmark dose (eBMD_HED) values. Abstract 4013, Society of Toxicology 65^th Annual Meeting, San Diego, CA, March 2026.

Mihalchik A. Strategies to evaluate over-the-counter drug degradants. Abstract 1252, Society of Toxicology 64^th Annual Meeting, Orlando, FL, March 2025.

Lea IA, Feifarek D, Mihalchik A, Heintz M, Haws L, Nyambego H, Goyak K, Palermo C, Borghoff SJ. 2025. Evaluation of the endocrine disrupting potential of Di-isodecyl phthalate. Curr Res Toxicol 8:100221; doi: 10.1016/j.crtox.2025.100221. PMID: 40041033.

Lea IA, Buerger AN, Feifarek D, Mihalchik A, Heintz MM, Haws LC, Nyambego H, Goyak K, Palermo C, Borghoff SJ. 2025. Evaluation of the endocrine disrupting potential of Di-isononyl phthalate. Curr Res Toxicol 8:100220; doi: 10.1016/j.crtox.2025.100220. PMID: 40092461. Corrigendum 8:100233; doi: 10.1016/j.crtox.2025.100233; PMID 40529321.

Mihalchik AL, Choksi NY, Roe AL, Wisser M, Whitaker K, Seibert D, Deore M, Pavlick L, Wikoff DS. 2024. Safety evaluation of 8 drug degradants present in over-the-counter cough and cold medications. Regul Toxicol Pharmacol 149(May):105621; doi: 10.1016/j.yrtph.2024.105621. PMID: 38608922.

Borghoff SJ, Feifarek D, Mihalchik A, Heintz M, Haws L, Nyambego H, Goyak K, Lea IA. Evaluation of the endocrine disrupting potential of di-isononyl phthalate. Abstract 3931, Society of Toxicology 63rd Annual Meeting, Salt Lake City, UT, March 2024. 

Lea IA, Feifarek D, Mihalchik A, Heintz M, Haws L, Nyambego H, Goyak K, Borghoff SJ. Evaluation of the endocrine disrupting potential of di-isodecyl phthalate. Abstract 3930, Society of Toxicology 63rd Annual Meeting, Salt Lake City, UT, March 2024.

Petrick J, Mihalchik A, Tiwary A, Kreidl L, Swartz C, Bhattarai N. Nonclinical safety evaluation of 1-monoacetin and 2-monoacetin as potential impurities in pharmaceutical excipients. Abstract 3107, Society of Toxicology 63rd Annual Meeting, Salt Lake City, UT, March 2024.

Mihalchik A, Wood M. Considerations for standardization and derivation of pediatric and neonatal tolerable exposure limits for extractable and leachable compounds from medical devices. Poster presented at Society of Toxicology 61st Annual Meeting, San Diego, CA, March 2022.

Tice RR, Bassan A, Amberg A, Anger LT, Beal MA, Bellion P, Benigni R, Birmingham J…, Mihalchik-Burhans AL, et al. 2021. In silico approaches in carcinogenicity hazard assessment: Current status and future needs. Comp Toxicol 20(Nov):100191; doi: 10.1016/j.comtox.2021.100191. PMID: 35368437.

Rogers EN, Mihalchik AL, Gad, SC. Comparison and analysis of discrepancies among commonly used Cramer decision tree methods in Toxtree software. Abstract 1517, Society of Toxicology 59th Annual Meeting, Virtual, 2020.

Mihalchik-Burhans AL, Rogers EN. 2019. Considerations for leachables and extractables testing. In: Gad S (ed), Integrated Safety and Risk Assessment for Medical Devices and Combination Products, pp. 239–263. Springer.

Mihalchik-Burhans AL, Sullivan DW. 2019. Bridging issues of route. In: Gad S (ed), Integrated Safety and Risk Assessment for Medical Devices and Combination Products, pp. 273–297. Springer.

Mihalchik-Burhans A. And you want this by when? Making the successful transition from the bench to consulting. Oral presentation at the American College of Toxicology 39th Annual Meeting, West Palm Beach, FL, November 2018.

Mihalchik AL, Rogers EN, Gad-McDonald SE, Sullivan DW Jr, Gad SC. Development of dermal permissible daily exposure (PDE) levels for elemental impurities by utilizing data from alternative routes. Poster presented at Society of Toxicology 57th Annual Meeting, San Antonio, TX, March 2018.