Dr. James E. Polli is Professor and Ralph F. Shangraw/Noxell Endowed Professor in Industrial Pharmacy and Pharmaceutics at the University of Maryland School of Pharmacy. He received a BS in Pharmacy from the Philadelphia College of Pharmacy and Science and a PhD in pharmaceutics from the University of Michigan. He is also co-director of the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), an FDA-funded collaborative agreement with the agency, and director of the online MS in Regulatory Science program. His two main research interests are: (1) maximizing oral bioavailability through formulation and chemical approaches and (2) developing public quality standards for oral dosage forms. He has published in the areas of dissolution, drug intestinal permeability, transporter substrate requirements, prodrug design, oral bioavailability, in vitro – in vivo correlation, and bioequivalence. Dr. Polli is a fellow of the American Association of Pharmaceutical Scientists, an editorial board member of several journals, an editor of Pharmaceutical Research, and a member of the FDA Pharmaceutical Science and Clinical Pharmacology Advisory Committee. He teaches professional pharmacy students and graduate students, and has served as advisor to 19 PhD graduates.
Selected Recent Publications
Oner ZG, Michel SLJ, and Polli JE (2017): Equivalence and regulatory approaches of non-biological complex drug products across United States, European Union, and Turkey. In press in NYAS.
Hofsäss MA, Souza J, Silva-Barcellos NM, Bellavinha KR, Abrahamsson B, Cristofoletti R, Groot DW, Parr A, Langguth P, Polli JE, Shah VP, Tajiri T, Mehta MU, Dressman JB (2017): Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Folic acid. DOI: 10.1016/j.xphs.2017.08.007. In press in J. Pharm Sci.
Martinez M, Mistry B, Lukacova V, Lentz K, Polli J, Hoag S, Dowling T, Kona R, Fahmy R. (2017): Exploring Canine-Human Differences in Product Performance. Part II: Use of Modeling and Simulation to Explore the Impact of Formulation on Ciprofloxacin In Vivo Absorption and Dissolution in Dogs. DOI: 10.1208/s12248-017-0055-y. AAPS J. 19:712-726
Dickinson PA, Kesisoglou F, Flangan T, Martinez MN, Mistry HB, Crison JR, Polli JE, Cruañes MT, Serajuddin AT, Müllertz A, Cook JA, Selen A. (2016): Optimizing Clinical Drug Product Performance: Applying Biopharmaceutics Risk Assessment Roadmap (BioRAM) and the BioRAM Scoring Grid. DOI: 10.1016/j.xphs.2016.07.024. J. Pharm. Sci. 105:3242-3255.
Li Q, Yang H; Guo D; Zhang T; Polli JE; Zhou H, and Shu Y. (2016): Effect of Ondansetron on Metformin Pharmacokinetics and Response in Healthy Subjects. DOI: 10.1124/dmd.115.067223. Drug Metab. Dispos. 44:489-94.
Raman S and Polli JE (2016): Prediction of Positive Food Effect: Bioavailability Enhancement of BCS Class II Drugs. DOI: 10.1016/j.ijpharm.2016.04.013. Int. J. Pharm. 506:110-115.
Goodarzi N, Morgani AB, Abrahamsson B, Cristofoletti R, Groot DW, Langguth P, Mehta MU, Polli JE, Shah VP, Dressman JB. (2016): Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Ribavirin. DOI: 10.1016/j.xphs.2016.01.017. J. Pharm. Sci. 105:1362-1369.
Vaithianathan, S., Haidar, S.H., Zhang, X., Jiang, W., Avon, C., Dowling, T.C., Kane, M.A., Hoag, S.W., Flasar, M.H., Ting, T.Y., and Polli, J.E. (2016): Lack of In Vivo Impact of Common Excipients on the Oral Drug Absorption of Biopharmaceutics Classification System Class 3 Drugs Cimetidine and Acyclovir. DOI: 10.1002/jps.24643. J. Pharm. Sci. 105:996-1005.
Ting, T.Y., Jiang, W., Lionberger, R., Wong, J., Jones, J.W., Kane, M.A., Krumholz, A., Temple, R., and Polli, J.E. (2015): Generic lamotrigine versus brand-name LAMICTAL bioequivalence in epilepsy patients: a field test of the FDA bioequivalence standard. DOI: 10.1111/epi.13095. Epilepsia 56:1415-24.
Vaithianathan S, Raman, S, Jiang W, Ting TY, Kane MA, and Polli JE. (2015): Biopharmaceutic Risk Assessment of Brand and Generic Lamotrigine Tablets. DOI: 10.1021/acs.molpharmaceut.5b00154. Mol Pharmaceutics 12: 2436−2443.
Dong Z, Ekins S, Polli JE. (2015): Quantitative NTCP Pharmacophore and Lack of Association between DILI and NTCP Inhibition. DOI:10.1016/j.ejps.2014.09.005. Eur. J. Pharm. Sci. 66:1-9.
Dong Z, Ekins S, and Polli J.E. (2015): A Substrate Pharmacophore for the Human Sodium Taurocholate Co-transporting Polypeptide. DOI:10.1016/j.ijpharm.2014.11.022. Int. J. Pharm. 478:88-95.
Vivian D, Cheng K, Khurana S, Xu S, Dawson PA, Raufman J-P, and Polli JE. (2014): Design and evaluation of a novel trifluorinated imaging agent for assessment of bile acid transport using fluorine magnetic resonance imaging (MRI). DOI: 10.1002/jps.24131. J. Pharm Sci. 103:3782-2792.
Vivian D. and Polli J.E. (2014): Synthesis and in vitro evaluation of bile acid prodrugs of floxuridine to target the liver. DOI:10.1016/j.ijpharm.2014.09.014. Int. J. Pharm. 475:597-604.