James Polli

James Polli, PhD, is a Professor and Ralph F. Shangraw/Noxell Endowed Chair in Industrial Pharmacy and Pharmaceutics in the Department of Pharmaceutical Sciences at the University of Maryland School of Pharmacy

Headshot of James Polli

James E. Polli, PhD
Professor and Ralph F. Shangraw/Noxell Endowed Chair in Industrial Pharmacy and Pharmaceutics
Department of Pharmaceutical Sciences
Health Sciences Facility II, Room 62320 Penn StreetBaltimore, MD 21201Phone: 410-706-8292
Email: jpolli@rx.umaryland.edu

Postdoctoral – Accepting applicants
PhD – Currently recruiting
MS – Currently recruiting

Education

PhD, Pharmaceutics, University of Michigan

BS, Pharmacy, Philadelphia College of Pharmacy and Science

Research Interests

Dr. Polli’s research focus is oral drug absorption. 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 served as advisor to 24 Ph.D. graduates. He is co-Director of the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) and the Center for Research on Complex Generics (CRCG), each an FDA-funded collaborative agreement with the Agency. He is Director of the online MS in Regulatory Science program. He is a fellow of the American Association for Pharmaceutical Scientists (AAPS) and served as an editor of its flagship journal Pharmaceutical Research for 12 years. He was the recipient of the 2022 AAPS Global Leadership Award and 2021 TOPRA Education Award.

Selected Publications

  1. Metry M., Krug SA, Karra VK, Ekins Kane MA, Fink JC, Shu Y, Wang H, JE Polli. (2022): Differential effects of metformin-mediated BSEP repression on pravastatin and bile acid pharmacokinetics in humans: A randomized controlled trial. DOI: 10.1111/cts.13375. Clin Transl Sci. In press.
  2. Adhikari A, Seo, PR, Polli, JE. (2022): Characterization of dissolution-permeation system using hollow fiber membrane module and utility to predict in vivo drug permeation across BCS classes. DOI: 10.1016/j.xphs.2022.07.002. J Pharm Sci. In press.
  3. Jamil R, Polli JE (2022): Prediction of food effect on in vitro drug dissolution into biorelevant media: Contributions of solubility enhancement and relatively low colloid diffusivity. DOI: 10.1016/j.ejps.2022.106274. Eur. J Pharm. Sci. 177: 106274.
  4. Metry, M., JE Polli. (2022): Evaluation of Excipient Risk in BCS Class I and III Biowaivers. DOI: 10.1208/s12248-021-00670-1. AAPS J. 24:20, 11 pages.
  5. Sydney Stern, Jill Coghlan, Vishalakshi Krishnan, Sam G. Raney, Andrew Babiskin, Wenlei Jiang, Robert Lionberger, Xiaoming Xu, Anna Schwendeman, and James E. Polli (2021): Research and Education Needs for Complex Generics. DOI:10.1007/s11095-021-03149-y. Pharm. Res. 38:1991-2001.
  6. Das S, Guo D, Jiang X, Jiang W, Shu Y, Ting TY, Polli JE (2020): Lack of association of generic brittle status with genetics and physiologic measures in patients with epilepsy. DOI: 10.1007/s11095-020-2781-6. Pharm Res. 37:60.
  7. Moshe Honick, Kanika Sarpal, Alaadin Alayoubi, Ahmed Zidan, Stephen W. Hoag, Robert G. Hollenbeck, Eric J. Munson, and James E. Polli (2019): Utility of Films to Anticipate Effect of Drug Load and Polymer on Dissolution Performance from Tablets of Amorphous Itraconazole Spray Dried Dispersions. DOI: 10.1208/s12249-019-1541-6. AAPS PharmSciTech. 20:331 (13 pages).
  8. 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.
  9. 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.
  10. 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.
  11. Polli, J.E. (2008): In Vitro Studies Are Sometimes Better than Conventional Human Pharmacokinetic In Vivo Studies in Assessing Bioequivalence of Immediate-release Solid Oral Dosage Forms. DOI: 10.1208/s12248-008-9027-6. AAPS J. 10:289-299.
  12. Tolle-Sander, S., Lentz, K.A., Maeda, D.Y., Coop, A., and Polli, J.E. (2004): Increased acyclovir oral bioavailability via a bile acid conjugate. Mol. Pharmaceutics 1:40-48.
  13. Polli, J.E. and McLean A.M. (2001): Novel direct curve comparison metrics for bioequivalence. Pharm. Res. 18:734-741.
  14. Lentz, K.A., Hayashi, J., Lucisano, L.J. and Polli, J.E. (2000): Development of a more rapid, reduced serum culture system for Caco-2 monolayers and application to biopharmaceutics classification system. Int. J. Pharm. 200(1): 41-51.
  15. Polli, J.E. and Ginski, M.J. (1998): Human drug absorption kinetics and comparison to Caco-2 monolayer permeabilities. Pharm. Res. 15:47-52.
  16. Polli, J.E., Rekhi, G.S., Augsburger. L.L., and Shah, V.P. (1997): Methods to compare dissolution profiles and a rationale for wide dissolution specifications for metoprolol tartrate tablets. J. Pharm. Sci. 86:690-700.
  17. Polli, J.E., Crison, J.R., and Amidon, G.L. (1996): A novel approach to the analysis of in vitro-in vivo relationships. J. Pharm. Sci. 85:753-760.