Publication Topic

Rudisill C, Jacobs M, Roy M, Brown L, Eaton R, Malloy T, Davies H, Tickner JT. 2024. The use of alternatives assessment in chemicals management policies: Needs for greater impact. Integr Environ Assess Manag 20(4):1035-1045; doi: 10.1002/ieam.4826. PMID: 37658263.

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.

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.

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, 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.

Casey WM, Chang X, Allen DG, Ceger PC, Choksi NY, Hsieh JH, et al. 2018. Evaluation and optimization of pharmacokinetic models for in vitro to in vivo extrapolation of estrogenic activity for environmental chemicals. Environ Health Perspect 126(9):97001; doi: 10.1289/EHP1655.

Wikoff D. Moving beyond theory to the use of systematic review to support regulatory decision making for evidence-based risk assessment. Society of Toxicology 57th Annual Meeting, San Antonio, TX, March 2018.

Proctor DM. Updating the regulatory risk assessment for hexavalent chromium in California: Implications for regulatory standards. Association of Environmental Health Sciences San Diego, CA, March 2018.

Drechsel DA, Barlow CA, Bare JL, Jacobs NF, Henshaw JL. 2018. Historical evolution of regulatory standards for occupational and consumer exposures to industrial talc. Regul Toxicol Pharmacol 92(Feb):251–267; doi: 10.1016/j.yrtph.2017.12.005.

Vincent MJ, Bernstein JA, Basketter D, LaKind JS, Dotson GS, Maier A. 2017. Chemical-induced asthma and the role of clinical, toxicological, exposure and epidemiological research in regulatory and hazard characterization approaches. Regul Toxicol Pharmacol 90(Nov):126–132; doi: 10.1016/j.yrtph.2017.08.018.

Ulrich K. Adversity and risk assessment of respiratory tract findings — A regulatory perspective. Presentation to the 31st Annual Meeting of the British Society of Toxicological Pathology (BSTP) — Association of Inhalation Toxicologists Joint Conference, Alderley Edge, Cheshire, UK, 2016.

Ulrich K. Inhalation toxicology – Regulatory aspects for pharmaceuticals. Presentation to In Vitro Toxicology Society Annual Meeting, Birmingham, UK, 2015.

Reddick H. An introduction to regulatory toxicology. Science Teachers and Industry Workshop, Kilgore, TX, 2015.

Sistare FD, Morton D, Alden C, Christensen J, Keller D, Jonghe SD, et al. 2011. An analysis of pharmaceutical experience with decades of rat carcinogenicity testing: Support for a proposal to modify current regulatory guidelines. Toxicol Pathol 39(4):716–744; doi: 10.1177/0192623311406935.

Tice RR, Choksi NY, Allen DG, Haseman JH, Hill R, Lewis M, et al. Estimation of the underprediction rates for the in vivo rabbit dermal corrosion assay. Poster presented at Society of Toxicology 43rd Annual Meeting, Baltimore, MD, March 2004.

Sauers L and Perry C. 1996. Regulatory affairs – A growing opportunity for toxicologists. SOT Communiqué, May/June 1996.