Publications

Rossi, Clifford V. Economics and Risks Associated with FDA’s QMM Rating Program. Robert H. Smith School of Business. University of Maryland. May 16, 2022.

Rossi, Clifford V. A Comparative Risk & Financial Analysis of Batch and Continuous Pharmaceutical Manufacturing Technologies. Robert H. Smith School of Business. University of Maryland. September 2021.

More information coming soon.

More information coming soon.

Doshi P, Spence O, Powers JH. (Jan. 2018) “Noninferiority Trials." N Engl J Med. 2018 18;378(3):304.

Gaitonde P, Bozzi L, Shaya FT, “Factors Associated with Use of Disease Modifying Agents for Rheumatoid Arthritis in the National Hospital and Ambulatory Medical Care Survey.” Under review in Seminars in Arthritis and Rheumatism Semin Arthritis Rheum. 2017 Oct 18. pii: S0049-0172(17)30463-8. doi: 10.1016/j.semarthrit.2017.10.011

Feemster AA, Calabrese M, Gaitonde P, Shaya FT, “Characteristics of Pharmacy Students Associated with a Successful PGY1 Residency Match.” Accepted for publication in Medical Science Educator. 2017   Am J Pharm Educ. 2016 Jun 25;80(5):84. doi: 10.5688/ajpe80584. 

Yang H, Guo D, Obianom ON, Su T, Polli JE; Shu Y. (2017): "Multidrug and toxin extrusion proteins mediate cellular transport of cadmium." Toxicology & Applied Pharmacology. 2017 Jan 1; 314:55-62. doi: 10.1016/j.taap.2016.11.007 

González P, Shah V, Langguth P, Polli JE (2017): Workshop Report: Implementation of Biowaivers based on the Biopharmaceutics Classification System. DOI: 10.14227/DT240417P46. Diss Technol 24:46-50.

Taraban, M.B., Truong, H., Ilavsky, J., DePaz, R.A., Lobo, B., Yu, Y.B. (2017): "Non-invasive detection of nanoparticle clustering by water proton NMR."  Transl. Mater. Res. 4, 025002. 

Yu, Y.B., Taraban, M.B., Wang, W., Briggs, K.T. (2017) "Improving biopharmaceutical safety through verification-based quality control."  Trends Biotechnol. Published on-line on Sep. 22, 2017.  DOI:  http://dx.doi.org/10.1016/j.tibtech.2017.08.010

Abdallah IA, Hammell DC, Hassan HE, Stinchcomb AL.  Norelgestromin/ethinyl estradiol intravenous infusion formulation optimization, stability and compatibility testing:  A case study to overcome polysorbate 80 interference in chromatographic analysis.  J Pharm Biomed Anal.  June 5; 125:  145-153 (2016) PMID:  27018506 [Funding:  U01FD004955 Heat Effect on Generic Transdermal Drug Delivery Systems]

Abdallah IA, Hammell DC, Stinchcomb AL, Hassan HE.  A fully validated LC-MS/MS method for simultaneous determination of nicotine and its metabolite cotinine in human serum and its application to a pharmacokinetic study after using nicotine transdermal delivery systems with standard heat application in adult smokers.  J Chromatogr B Analyt Technol Biomed Life Sci.  May 1; 1020:  67-77 (2016) PMID:  27023159 [Funding:  U01FD004955 Heat Effect on Generic Transdermal Drug Delivery Systems]

Bhaveshkumar H. Kothari, Raafat M. Fahmy, Gregg Claycamp, Christine M. V. Moore, Sharmista Chatterjee and Stephen W. Hoag. "A Systematic Approach of Employing Quality by Design Principles: Risk Assessment and Design of Experiments to Demonstrate Process Understanding and Identify the Critical Process Parameters for Coating of the Ethylcellulose Pseudolatex Dispersion Using Non-Conventional Fluid Bed Process." AAPS PharmSciTech  (2016) DOI: 10.1208/s12249-016-0569-0

Bhaveshkumar H. Kothari, Raafat M. Fahmy, Gregg Claycamp, Christine M. V. Moore, Sharmista Chatterjee and Stephen W. Hoag, A Systematic Approach of Employing Quality by Design Principles: Risk Assessment and Design of Experiments to Demonstrate Process Understanding and Identify the Critical Process Parameters for Coating of the Ethylcellulose Pseudolatex Dispersion Using Non-Conventional Fluid Bed Process. AAPS PhamSciTech, In press (2016). DOI: 10.1208/s12249-016-0569-0.

Claycamp HG, Kona R, Fahmy R, Hoag SW. Quality-by-Design II: Application of Quantitative Risk Analysis to the Formulation of Ciprofloxacin Tablets. AAPS PharmSciTech. 2016 Apr;17(2):233-44. doi: 10.1208/s12249-015-0349-2.

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." J Pharm Sci. 2016 Nov;105(11):3243-3255. doi: 10.1016/j.xphs.2016.07.024. Epub 2016 Sep 19.

Goodarzi N, Morgani AB, Abrahamsson B, Cristofoletti R, Groot DW, Langguth P, Mehta MU, Polli JE, Shah VP, Dressman JB: Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Ribavirin. DOI: 10.1016/j.xphs.2016.01.017. April 2016. J. Pharm. Sci. 105:1362-1369.

Kim, YW, Meyer, MT, Berkovich, A, Subramanian, S, Iliadis, AA, Bentley, WE, Ghodssi, R. A surface acoustic wave biofilm sensor integrated with a treatment method based on the bioelectric effect. February 2016. Sensors and Actuators. 238: 140-149, 2016. DOI: 10.1016/j.sna.2015.12.001

Kim, YW, Mosteller, MP, Subramanian, S, Meyer, MT, Bentley, WE, Ghodssi, R. An optical microfluidic platform for spatiotemporal biofilm treatment monitoring. Journal of Micromechanics and Microengineering. DOI 10.1088/0960-1317/26/1/015013. 2016.

Li Q, Yang H, Guo D, Zhang T, Polli JE, Zhou H, Shu Y. Effect of Ondansetron on Metformin Pharmacokinetics and Response in Healthy Subjects. Drug Metab Dispos. 2016 Apr;44(4):489-94. doi: 10.1124/dmd.115.067223. Epub 2016 Jan 29. PMID: 26825640

Martinez M, Mistry B, Lukacova V, Polli J, Hoag S, Dowling T, Kona R, Fahmy R. (2016): Use of Modeling and Simulation Tools for Understanding the Impact of Formulation on the Absorption of a Low Solubility Compound: Ciprofloxacin. DOI:10.1208/s12248-016-9913-2. AAPS J. 18:886-97. Epub 26 April 2016.

Quan, DN, Tsao, CY, Wu, HC., Bentley, WE. Quorum Sensing Desynchronization Leads to Bimodality and Patterned Behaviors. PLoS Computational Biology. 2016 April. 12(4). e1004781. DOI: 10.1371/journal.pcbi.1004781. 2016.  

Raman S. and Polli J.E. (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.

Rozner M.A., Schultheis L., and Schulman P.M. The Unstated Murphy's Law of the Operating Room: If Something Goes Wrong, Blame Anesthesia. A Case Rep. 2016 Mar 15;6(6):139-41. doi: 10.1213/XAA.0000000000000262. PubMed PMID: 26954079.

Servinsky, MD, Terrell, JL, Tsao, CY, Wu, HC, Quan, DN, Zargar, A, Allen, PC, Byrd, CM, Sund, CJ, Bentley, WE. Directed Assembly of a Bacterial Quorum. ISME Journal. 10(1):158-169. DOI: 10.1038/ismej.2015.89. 2016.   

Sumbramanian, S., Gerasopooulos, K., Guo, M., Sintim, H.O., Bentley, W.E., Ghodssi R., Investigation of the Combination of Autoinducer-2 Analogs and Electric Fields as a High-Efficacy Bacterial Biofilm Treatment. Biomicrofluidics.

Subramanian, S., Gerasopoulos, K., Guo, M., Sintim, H.O., Bentley, W.E., Ghoddsi, R., Autoinducer-2 Analogs and Electric Fields - An Antibiotic-Free Bacterial Biofilm Combination Treatment. Biomedical Microdevices. 

Tschirhart, T, Zhou, XYY, Ueda, H, Tsao, CY, Kim, E, Payne, GF, Bentley, WE. Electrochemical Measurement of the beta-Galactosidase Reporter from Live Cells: A Comparison to the Miller Assay. ACS Synthetic Biology. 5(1):28-35. DOI: 10.1021/acssynbio5b00073. 2016. 

Vaithianathan S., Haidar S.H., Zhang X., Jiang W., Avon C., Dowling T.C., Shao C., Kane M., Hoag S.W., Flasar M.H., Ting T.Y., and Polli J.E. Effect of Common Excipients on the Oral Absorption of Biopharmaceutics Classification System Class 3 Drugs Cimetidine and Acyclovir. J Pharm Sci. 2016 Feb;105(2):996-1005. doi: 10.1002/jps.24643. Epub 2016 Jan 12.

Vaithianathan S., Ting T.Y., Jiang W., and Polli J.E. (2016): Release of levetiracetam from extended-release tablets that appear intact in patient stool.  DOI: 10.1016/j.seizure.2016.05.011. In press in Seizure-Eur. J. Epilep.

Wang, MO, Vorwald, CE, Dreher, ML, Mott, EJ, Cheng, MH, Cinar, A, Mehdizadeh, H, Somo, S, Dean, D, Brey, EM, Fisher, JP. Evaluating 3D-Printed Biomaterials as Scaffolds for Vascularized Bone Tissue Engineering. Advanced Materials. 27(1):138-144. 2026. DOI: 10.1002/adma.201403943.

Yu LX, Akseli, I, Allen B, Amidon G, Gooen Bizjak T, Boam A, Caulk M, Doleski D, Famulare J, Fisher AC, Furness S, Hasselbalch B, Havel H, Hoag SW, Iser R, Johnson BD, Ju R, Katz P, Lacana E, Lee SL, Lostritto R, McNally G, Mehta M, Mohan G, Nasr M, Nosal R, Oates M, O’Connor T, Polli J, Raju1 GK, Ramanadham M, Randazzo G, Rosencrance S, Schwendeman A, Selen A, Seo P, Shah V, Sood R, Thien MP, Tong T, Trout BL, Tyner K, Vaithiyalingam S, VanTrieste M, Walsh F, Wesdyk R, Woodcock J, Wu G, Wu L, Yu L, Zezza D.: Advancing Product Quality: A Summary of the Second FDA/PQRI Conference. March 2016. DOI: 10.1208/s12248-016-9874-5. AAPS J. 18:528-543.

Albrecht J.S., Khokhar B., Pradel F., Campbell M., Palmer J., Harris I., and Palumbo F. Perceptions of patient provider agreements. J Pharm Health Serv Res. 2015. Sept;6(3):139-144.doi:10.1111/jphs.12099.

Dong Z., Ekins S., Polli J.E. (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.

Dong Z., Li Q., Shu Y., Polli J.E. (2015): Synthesis and Evaluation of Bile acid-ribavirin Conjugates as Prodrugs to Target the Liver. DOI: 10.1002/jps.24375. J. Pharm Sci. 104:2864-76.   

Feng Y, Taraban MB, Yu YB. Water proton NMR-a sensitive probe for solute association. Chem Commun (Camb). 2015 Apr 21;51(31):6804-7. doi: 10.1039/c5cc00741k.

Gajendran J, Krämer J, Shah VP, Langguth P, Polli J, Mehta M, Groot DW, Cristofoletti R, Abrahamsson B, Dressman JB: Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Nifedipine. October 2015. DOI: 10.1002/jps.24560. J. Pharm Sci. 104:3289-98.

Ghassemi P., Wang J., Melchiorri A.J., Ramella-Roman J.C., Mathews S.A., Coburn J.C., Sorg B.S., Chen Y., and Pfefer T.J. 3D Printed Biomimetic Vascular Phantoms for Assessment of Hyperspectral Imaging and Diffuse Reflectance Systems. J Biomed Opt. 2015;20(12):121312. doi: 10.1117/1.JBO.20.12.121312.

Harris Howland, Raafat M. Fahmy and Stephen W. Hoag, Analysis of Curing of a Sustained Release Coating Formulation by Application of NIR Spectroscopy to Monitor Changes Associated with Glyceryl Monostearate, Drug Dev. Ind. Pharm., 41(8):1263-1273 (2015). DOI: 10.3109/03639045.2014.947505.

Kona R, Fahmy RM, Claycamp G, Polli JE, Martinez M, and Hoag SW. (2015): Quality-by-Design III: Application of Near-Infrared Spectroscopy to Monitor Roller Compaction In-process and Product Quality Attributes of Immediate Release Tablets. DOI: 10.1208/s12249-014-0180-1. AAPS PharmSciTech.

Meyer, MT, Subramanian, S, Kim, YW, Ben-Yoav, H, Gnerlich, M, Gerasopoulos, K, Bentley, WE, Ghodssi, R. Multi-depth valved microfluidics for biofilm segmentation. Journal of Micromechanics and Microengineering. 10.1088/0960-1317/25/9/095003. 2015.

Moolchandani Vikas , Larry L. Augsburger, Abhay Gupta, Mansoor Khan, John Langridge, and Stephen W. Hoag, To investigate the influence of machine operating variables on formulations derived from lactose types in capsule filling: Part 2, Drug Dev. Ind. Pharm. Early-online (2015). DOI: 10.3109/03639045.2015.1062511

Raufman JP, Dawson PA, Rao A, Drachenberg CB, Heath J, Shang AC, Hu S, Zhan M, Polli JE, Cheng K. (2015): Slc10a2-null mice uncover colon cancer-promoting actions of endogenous fecal bile acids. DOI: 10.1093/carcin/bgv107. Carcinogenesis. 36:1193-200.

Schultheis L. Academic Involvement: A Treatment for Regulatory Fatigue. Anesth Analg. 2015 Aug;121(2):255-8. doi: 10.1213/ANE.0000000000000816. PubMed PMID: 26197363.

Taraban, M.B., Truong, H.C., Feng, Y., Jouravleva, E.V.,  Anisimov, M.A.,  and Yu, Y.B. (2015). Water proton NMR for in situ detection of insulin aggregates.  J. Pharm. Sci., Dec;104(12):4132-41. doi:10.1002/jps.24633. Epub 2015 Sep 7.

Ting T.Y., Jiang W., Lionberger R., Wong J., Jones J.W., Kane M.A., Krumholz A., Temple R., and Polli J.E. Generic Lamotrigine Versus Brand-Name Lamictal Bioequivalence in Patients With Epilepsy: A Field Test of the FDA Bioequivalence Standard. Epilepsia 2015;56(9):1415–1424. doi:10.1111/epi.13095.

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.

Vivek S. Dave, Raafat M. Fahmy and Stephen W. Hoag, Near-infrared spectroscopic analysis of the breaking force of extended-release matrix tablets prepared by roller-compaction: influence of plasticizer levels and sintering temperature, Drug Dev. Ind. Pharm., 41(6):898-905 (2015). DOI: 10.3109/03639045.2014.911883.

Yang H, Shu Y. Cadmium Transporters in the Kidney and Cadmium-Induced Nephrotoxicity. Int. J. Mol. Sci. 2015, 16, 1484-1494; doi:10.3390/ijms16011484.

Wang M.O., Piard C., Melchiorri A.J., Dreher M.L., and Fisher J.P. Evaluating Changes in Structure and Cytotoxicity During In Vitro Degradation of 3D Printed Scaffolds. Tissue Engineering, Part A. 21: 1642-1653 (2015).

Wang M.O.,  Vorwald C.E., Dreher M.L., Mott E.J., Cheng M.H., Cinar A., Mehdizadeh H., Somo S., Dean D., Brey E.M., and Fisher J.P. Evaluating 3D Printed Biomaterials as Scaffolds for Vascularized Bone Tissue Engineering. Advanced Materials. 27: 138-144 (2015).

Wong, J.M, Jones, J.W., Jiang, W., Polli, J.E., and Kane, M.A. (2015): Quantification of lamotrigine in patient plasma utilizing a fast liquid chromatography-tandem mass spectrometry method with backflush technology. DOI: 10.1097/FTD.0000000000000123. Ther. Drug Monit. 37:188-197.

Bowen L., Carter-Pokras O.,  and Kohrt B.: Health Literacy and Cultural Competency of FDA Consumer Materials. Annals of Epidemiology 2014, 24(9):668.

Dean D., Mott E., Luo X., Busso M., Wang M.O., Vorwald C., Siblani A., and Fisher J.P. Multiple Initiators and Dyes for Continuous Digital Light Processing (cDLP) Additive Manufacture of Resorbable Bone Tissue Engineering Scaffolds. Virtual and Phys Prototyp 2014, 9: 3-9.

Dong Z., Ekins S., and Polli J.E.: 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.: 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.

Dong, Z., Ekins, S., and Polli, J.E.: Structure Activity Relationship for FDA Approved Drugs as Inhibitors of the Human Sodium Taurocholate Co-transporting Polypeptide (NTCP). DOI: 10.1021/mp300453k. Mol. Pharmaceutics. 10: 1008-1019.

Gandhi, S., Rodriguez, W., Khan, M., and Polli, J.E. (2014): Considerations for a Pediatric Biopharmaceutics Classification System (BCS): Application to Five Drugs. DOI: 10.1208/s12249-014-0084-0. June 2014. AAPS PharmSciTech. 15:601-611.

Garzel B., Yang H., Lynch C., Zhang L., Huang S., Polli J., and Wang H. The role of bile salt export pump gene repression in drug-induced cholestatic liver toxicity. Drug Metab Dispos 2014, 42(3):318-322.

Gordonov T., Kim E., Cheng Y., Ben-Yoav H., Ghodssi R., Rubloff G., Yin J.J., Payne G.F., and Bentley W.E. Electronic modulation of biochemical signal generation. Nat Nanotechnol. 2014 Aug;9(8):605-10. doi: 10.1038/nnano.2014.151. Epub 2014 Jul 27.

Li, M., Tan J.,  Tarlov M., and Zachariah, M.R.. Absolute Quantitative Method for Protein Concentration.  November 2014. Analytical Chemistry, 86, 12130 (2014) DOI: 10.1021/ac5030123

Li Q., and Shu Y. Role of solute carriers in response to anticancer drugs. Molecular and Cellular Therapies 2014, 2(15).

Li Q., and Shu Y. Pharmacological modulation of cytotoxicity and cellular uptake of anti-cancer drugs by PDE5 inhibitors in lung cancer cells. Pharm Res 2014, 31(1):86-96.

Moolchandani Vikas , Larry L. Augsburger, Abhay Gupta, Mansoor Khan, John Langridge, and Stephen W. Hoag, Characterization and selection of suitable grades of lactose as functional fillers for capsule filling: part 1, Drug Dev. Ind. Pharm. Early-online (2014). DOI: 10.3109/03639045.2014.957703

Palmer J.B., Albrecht J.S., Park Y., Dutcher S., Rattinger G.B., Simoni-Wastila L., Walker L.D., and Zuckerman I.H. Use of drugs with anticholinergic properties among nursing home residents with dementia: a national analysis of Medicare beneficiaries from 2007 to 2008. Drugs and Aging. Published online 10 December 2014. DOI 0.1007/s40266-014-0227.

Selen A, Dickinson PA, Müllertz A, Crison JR, Mistry HB, Cruañes MT, Martinez MN, Lennernäs H, Wigal TL, Swinney DC, Polli JE, Serajuddin AT, Cook JA, Dressman JB. 2014: The biopharmaceutics risk assessment roadmap for optimizing clinical drug product performance. September 2014. DOI: 10.1002/jps.24162. J. Pharm Sci. 103:3377-97.

Terrell, JL, Wu, HC, Tsao, CY, Barber, NB, Servinsky, MD, Payne, GF, Bentley, WE. Nano-guided cell networks as conveyors of molecular communication. Nature Communications. 6:8500. DOI: 10.1038/ncomms9500. 2015.

Vivian D., Cheng K., Khurana S., Xu S., Kriel E.H., Dawson P.A., Raufman J.P., and Polli J.E. In vivo performance of a novel fluorinated Magnetic Resonance Imaging agent for functional analysis of bile acid transport. Mol Pharm 2014, 11(5):1575-1582.

Vivian D., Cheng K., Khurana S., Xu S., Dawson P.A., Raufman J.P., and Polli J.E. (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.PharmSc.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.

Vivian D., and Polli J.E. Mechanistic interpretation of conventional Michaelis-Menten parameters in a transporter system. Eur J Pharm Sci 2014, 64:44-52. 

Wallace J., Wang M.O., Thompson P., Busso M., Belle V., Mammoser N., Kim K., Fisher J.P., Siblani A., Xu Y., Welter J.F., Lennon D.P., Sun J., Caplan A.L., and Dean D.: Validating continuous digital light processing (cDLP) additive manufacturing accuracy and tissue engineering utility of a dye-initiator package. Biofabrication 2014, 6(1):015003.

Wang J., Coburn J., Woolsey N., Liang C.P., Ramella-Roman J., Chen Y., Pfefer J.: Quantitative assessment of biophotonic imaging system performance with phantoms fabricated by rapid prototyping. Proceedings of SPIE 2014, 89360M. doi: 10.1117/12.2044089.

Wang J., Coburn J., Liang C.P., Woolsey N., Ramella-Roman J.C., Chen Y., Pfefer T.J. Three-dimensional printing of tissue phantoms for biophotonic imaging. Opt Lett 2014, 39(10):3010-3013.

Yu, L.X., Amidon, G., Khan, K.A., Hoag, S.W., Polli, J.E., Raju, G.K., and Woodcock, J. (2014): Understanding Pharmaceutical Quality by Design. DOI: 10.1208/s12248-014-9598-3. AAPS J. 16:771-783.