Publication Topic

Liu W, Hussain Z, Zang Y, Sweis RF, Romero FA, Finke PE, … Dingley KH, et al. 2018. Optimization of preclinical metabolism for somatostatin receptor subtype 5-selective antagonists. ACS Med Chem Lett (9):1088–1093; doi: 10.1021/acsmedchemlett.8b00306. PMID: 30429950.

DeGeorge J, Robertson S, Butler L, Derzi M, Stoch SA, Diaz D, Hartke J,…, Greene N. 2018. An industry perspective on the 2017 EMA guideline on first‐in‐human and early clinical trials. Clin Pharm Ther 103(4):566-569; doi: 10.1002/cpt.984. PMID: 29285748.

Winiwarter S, Ahlberg E, Watson E, Oprisiu I, Mogemark M, Noeske T, Greene N. 2018. In silico ADME in drug design–Enhancing the impact. ADMET DMPK 6(1):15-33; doi: 10.5599/admet.6.1.470.

Fisk L, Greene N, Naven R. 2018. Physicochemical properties and structural alerts. In: Chen M, Will Y (eds), Drug-Induced Liver Toxicity, Humana: New York, pp. 61-76; doi: 10.1007/978-1-4939-7677-5_4.

Butler L, Guzzie-Peck P, Hartke J, Bogdanffy M, Will Y, Diaz D, Mortimer-Cassen E,.., Greene N, et al. Revised draft EMA guidance on early clinical trials: Potential impacts and industry response. Abstract P204, American College of Toxicology 2017 Annual Meeting, Palm Springs, CA, 2017. Int J Toxicol 37(1):75-76; doi: 10.1177/10915818177494, 2018.

Sanz F, Pognan F, Steger-Hartmann T, Díaz C, Cases M, Pastor M, Marc P,…, Greene N, et al. 2017. Legacy data sharing to improve drug safety assessment: The eTOX project. Nat Rev Drug Discov 6(12):811-812; doi: 10.1038/nrd.2017.177. PMID: 29026211.

Lansita J,  Mease KM, Qiu H, Yednock T, Sankaranarayanan S, Kramer S. 2017. Nonclinical development of ANX005: A humanized anti-Clq antibody for treatment of autoimmune and neurodegenerative diseases. Int J Toxicol 36(6)449-462; doi: 10.1177/1091581817740873. PMID: 29202623.

Butler LD, Guzzie-Peck P, Hartke J, Bogdanffy MS, Will Y, Diaz D, Mortimer-Cassen E,…, Greene N, et al. 2017. Current nonclinical testing paradigms in support of safe clinical trials: An IQ Consortium DruSafe perspective. Regul Toxicol Pharmacol 87(Sup 3):S1-S15; doi: 10.1016/j.yrtph.2017.05.009. PMID: 28483710.

Mease K, Kimzey A, Lansita J. Failed dose formulation analysis during a GLP study — Now what? Poster presented at Society of Toxicology 56th Annual Meeting, Baltimore, MD, March 2017.

Edmondson SD, Zhu C, Kar NF, Di Salvo J, Nagabukuro H, Sacre-Salem B, Dingley K, et al. 2016. Discovery of vibegron: A potent and selective beta 3 adrenergic receptor agonist for the treatment of overactive bladder. J Med Chem 59(2):609–623; doi: 10.1021/acs.jmedchem.5b01372. PMID: 26709102.

Shah F, Leung L, Barton HA, Will Y, Rodrigues AD, Greene N, Aleo MD. 2015. Setting clinical exposure levels of concern for drug-induced liver injury (DILI) using mechanistic in vitro assays. Toxicol Sci 147(2):500-14; doi: 10.1093/toxsci/kfv152. PMID: 26206150.

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.

Shah F, Hashimoto T, Segall MD, Greene N. 2014. Finding the rules for successful drug optimization. Drug Discov Today 18(13-14):659-666; doi: 10.1016/j.drudis.2014.01.005.

Davis PA, Wiegers TC, Roberts PM, King BL, Lay JM, Lennon-Hopkins K, Sciaky D,…, Greene N, et al. 2013. A CTD–Pfizer collaboration: Manual curation of 88 000 scientific articles text mined for drug–disease and drug–phenotype interactions. Database 2013(Nov 28):bat080; doi: 10.1093/database/bat080. PMID: 24288140.

Greene N, Gosink M. 2013. Computational toxicology experience and applications for risk assessment in the pharmaceutical industry. Chapter 10 in: Fowler BA (ed), Computational Toxicology: Methods and Applications. Elsevier-Academic Press, pp. 171-193; doi: 10.1016/B978-0-12-396461-8.00012-9.

Naven RT, Swiss R, Klug-McLeod J, Will Y, Greene N. 2013. The development of structure-activity relationships for mitochondrial dysfunction: Uncoupling of oxidative phosphorylation. Toxicol Sci 131(1):271-278; doi: 10.1093/toxsci/kfs279. PMID: 22977170.

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 A, Halbert RJ, Baerwaldt T, Nordyke RJ. 2012. U.S. payer perspectives on evidence for formulary decision-making. J Oncol Pract 8(3 Suppl):22s-27s; doi: 10.1200/JOP.2011.000526. PMID: 22942820.

Boyer S, Muthas D, Greene N. 2011. Information, informatics and modeling in predictive toxicology. Chapter 5 in: Wilson AG, Rotella D, (eds), New Horizons in Predictive Toxicology: Current Status and Application. RSC Drug Discovery Series, Vol. 12. Royal Society of Chemistry Publishing, pp. 70-100; doi: 10.1039/9781849733045-00070.

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