Publications

drug development (13 POSTS)

2025 (1 POST)

Nonclinical safety assessment: An overview of drug and medical device development

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, 3rd edition. Boca Raton: CRC Press-Taylor and Francis Group, pp. 3-51.

2022 (2 POSTS)

Characterization of false positive, contaminant- driven mutagenicity in impurities associated with the sotorasib drug substance

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.

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Testing of reproducibility of a high-throughput liver microphysiological system (OrganoPlate 2-lane plate) for studies of pharmacokinetics and toxicological assessment of drugs

Kato Y, Lim A, Sakolish C, Valdiviezo A, Moyer H, Rusyn I. Testing of reproducibility of a high-throughput liver microphysiological system (OrganoPlate 2-lane plate) for studies of pharmacokinetics and toxicological assessment of drugs. Abstract 4639, Society of Toxicology 61st Annual Meeting, San Diego, CA, March 2022.

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2019 (1 POST)

Integration of consortia recommendations for justification of animal use within current and future drug development paradigm

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.

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2018 (1 POST)

Nonclinical safety evaluation of drugs

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, 2nd edition. Boca Raton: CRC Press-Taylor and Francis Group, pp. 27-64.

2015 (1 POST)

Drug development and nonclinical to clinical translational databases: Past and current efforts

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.

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2012 (1 POST)

Nonclinical safety evaluation of drugs

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.

2011 (1 POST)

Toxicology in the nonclinical development of drugs and biologics

Robison TW. Toxicology in the nonclinical development of drugs and biologics. Pharmaceutical Education and Research Institute, Genetic Toxicology, Arlington, VA, October 2011.

2009 (1 POST)

Toxicology in the nonclinical development of drugs and biologics

Robison TW. Toxicology in the nonclinical development of drugs and biologics. Pharmaceutical Education and Research Institute, Genetic Toxicology, Arlington, VA, September 2009.

2008 (1 POST)

Toxicology in the nonclinical development of drugs and biologics

Robison TW. Toxicology in the nonclinical development of drugs and biologics. Pharmaceutical Education and Research Institute, Genetic Toxicology, Arlington, VA, September 2008.

2007 (1 POST)

Toxicology in the nonclinical development of drugs and biologics

Robison TW. Toxicology in the nonclinical development of drugs and biologics. Pharmaceutical Education and Research Institute, Genetic Toxicology, Arlington, VA, September 2007.

2006 (2 POSTS)

Toxicology in the nonclinical development of drugs and biologics

Robison TW. Toxicology in the nonclinical development of drugs and biologics. Pharmaceutical Education and Research Institute, Genetic Toxicology, Arlington, VA, September 2006.

Novel fluoro-substituted campthothecins: In vivo antitumor activity, reduced gastrointestinal toxicity and pharmacokinetic characterization

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.

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