Publications

Monticello TM, MacLachlan TK, Funk KA, Rock BM, Bussiere JL, Grieves JL, Schuh JCL, Henry S. 2025. Nonclinical safety assessment: An overview of drug and medical device development. Chapter 1 in: Bouchard PR, Sahota PS, Wallace S, Wojcinski ZW, Schumacher VL (eds), Toxicologic Pathology: Nonclinical Safety Assessment, 3^rd edition. Boca Raton: CRC Press-Taylor and Francis Group, pp. 3-51.

Monticello TM, Potter DM, Huang Q, Hart TK, Shuey D, Troth S, Vergis JM, Tassew N, et al. 2024. Do longer duration nonclinical toxicology studies provide predictive clinical safety value? The IQ Consortium longer duration nonclinical to clinical translational database. Toxicol Appl Pharmacol 492(Sept 5):117087; doi: 10.1016/j.taap.2024.117087.

Bienvenu JG, Chouinard L, Felix M, Boyce, RW, Monticello TM. 2024. Inhibition of both sclerostin and DKK1 results in novel skull findings in the rat and non-human primate that is not observed with inhibition of sclerostin alone. Bone 179(Feb):116985; doi: 10.1016/j.bone.2023.116985.

Coppi A, Davies R, Wegesser T, Ishida K, Karmel J, Han J, Aiello F, Xie Y…, Monticello TM, et al. 2022. Characterization of false positive, contaminant- driven mutagenicity in impurities associated with the sotorasib drug substance. Regul Toxicol Pharmacol 131(June):105162; doi: 10.1016/j.yrtph.2022.105162.

Werner JA, Davies R, Wahlstrom J, Dahal UP, Jiang M, Stauber J, David B, Siska W…, Monticello TM. 2021. Mercapturate pathway metabolites of sotorasib, a covalent inhibitor of KRASG12C, are associated with renal toxicity in the Sprague Dawley rat. Toxicol Appl Pharmacol 423(July 15):11578; doi: 10.1016/taap.2021.115578.

Ishida K, Werner J, Lafleur N, Wisler J, Wannberg S, Kalanzi J, Bussiere J, Monticello TM. 2021. Phosphatidylinositol 3-kinase δ-specific inhibitor-induced changes in the ovary and testis in the Sprague Dawley rat and cynomolgus monkey. Int J Toxicol 40(4):344-354; doi: 10.1177/109158211008175.

Bogdanfy MS, Lesnick J, Mangipudy R, Sistare FD, Colman K, Garcia-Tapla D, Monticello T, Blanset D. 2020. Tg.rasH2 mouse model for assessing carcinogenic potential of pharmaceuticals: Industry survey of current practices. Int J Toxicol 39(3):198-206; doi: 10.1177/1091581820919896.

Bussiere JL, Davies R, Dean C, Xu C, Kim KH, Vargas HM, Chellman GJ, Balasubramanian G, Monticello TM. 2019. Nonclinical safety evaluation of erenumab, a CGRP receptor inhibitor for the prevention of migraine. Regul Toxicol Pharmacol 106(Aug):224-238; doi: 10.1016/j.yrtph.2019.05.013.

Prior H, Monticello T, Boulifard V, Brennan FR, Kimber I. 2019. Integration of consortia recommendations for justification of animal use within current and future drug development paradigms. Int J Toxicol 38(4):319-325; doi: 10.1177/1091581819852922.

Monticello TM, Bussiere JL. 2018. Nonclinical safety evaluation of drugs. Chapter 2 in: Sahota PS, Popp JA, Hardisty JF, Gopinath C. (eds), Toxicologic Pathology: Nonclinical Safety Assessment, 2^nd edition. Boca Raton: CRC Press-Taylor and Francis Group, pp. 27-64.

Monticello TM, Jones TW, Dambach DM, Potter DM, Bolt MW, Liu M, Keller DA, Hart TK, et al. 2017. Current nonclinical testing paradigm enables safe entry to First-in-Human clinical trials: The IQ consortium nonclinical translational database. Toxicol Appl Pharmacol 334(Nov 1):100-109; doi: 10.1016/j.taap.2017.09.006.

Monticello TM. 2015. Drug development and nonclinical to clinical translational databases: Past and current efforts. Toxicol Pathol 43(1):57-61; doi: 10.1177/0192623314557189.

Monticello TM, Bussiere JL. 2012. Nonclinical safety evaluation of drugs. Chapter 2 in: Sahota PS, Popp JA, Hardisty JF, Gopinath C. (eds), Toxicologic Pathology: Nonclinical Safety Assessment. Boca Raton: CRC Press-Taylor and Francis Group, pp. 25-54.

Wang X, Hsu M-Y, Steinbacher TE, Monticello TM, Schumacher WA. 2007. Quantification of platelet composition in experimental venous thrombosis by real-time polymerase chain reaction. Thromb Res 119(5):595-600; doi: 10.1016/j.thromres.2006.04.011.

Rose WC, Marathe PH, Jang G, Monticello TM, Balasubramanian BN, Long B, Fairchild C, Wall ME, Wani MC. 2006. Novel fluoro-substituted campthothecins: In vivo antitumor activity, reduced gastrointestinal toxicity and pharmacokinetic characterization. Cancer Chemother Pharmacol 58(1):73-85; doi: 10.1007/s00280-005-0128-y.

Trippodo NC, Fox M, Monticello TM, Panchal BC, Asaad MM. 1999. Vasopeptidase inhibition with omapatrilat improves cardiac geometry and survival in cardiomyopathic hamsters more than does ACE inhibition with captopril. J Cardiovasc Pharmacol 34(6):782-790; doi: 10.1097/00005344-199912000-00003.

Bolton L, Zaki G, Monte K, Durham SK, Monticello TM, Hudak J, Shannon R, Wilfinger W, et al. 1997. Tissue repair in space. Wounds 9(4):127-142.

Aversa CA, Oparil S, Caro J, Li H, Sun S, Chen YF, Swerde MR, Monticello TM, et al. 1997. Hypoxia stimulates human preproendothelin-1 (PPET-1) promoter activity in transgenic mice. Am J Physiol 273(4):L848-L855; doi: 10.1152/ajplung.1997.273.4.L848.

Grover GJ, Dzwonczyk S, Monticello TM. 1996. Comparative cardioprotective effects of cromakalin and diltiazem in ischemic hypertrophied and non-hypertrophied rat hearts. Am J Physiol 270(1 Pt 2):H174-H182; doi: 10.1152/ajpheart.1996.270.1.H174.

Monticello TM, Swenberg JA, Gross EA, Leininger JR, Kimbell JS, Seilkop S, Starr TS, Gibson JE, et al. 1996. Correlation of regional and nonlinear formaldehyde-induced nasal cancer with proliferating populations of cells. Cancer Res 56(5):1012-1022.