Publications by authors named "James E Polli"

124 Publications

Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Carbamazepine.

J Pharm Sci 2021 Feb 18. Epub 2021 Feb 18.

Pharmaceutical Technology and Biopharmaceutics, Institute of Pharmaceutical and Biomedical Sciences, Johannes Gutenberg University, Mainz, Germany. Electronic address:

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February 2021

Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Metformin Hydrochloride.

J Pharm Sci 2021 Jan 13. Epub 2021 Jan 13.

Department of Pharmaceutical Sciences, School of Pharmacy, University of Maryland, Baltimore, MD, USA. Electronic address:

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January 2021

The effects of spray drying, HPMCAS grade, and compression speed on the compaction properties of itraconazole-HPMCAS spray dried dispersions.

Eur J Pharm Sci 2020 Dec 16;155:105556. Epub 2020 Sep 16.

University of Maryland, Department of Pharmaceutical Sciences, 20 Penn Street, Baltimore, MD 21201, USA. Electronic address:

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December 2020

Characterization of Grades of HPMCAS Spray Dried Dispersions of Itraconazole Based on Supersaturation Kinetics and Molecular Interactions Impacting Formulation Performance.

Pharm Res 2020 Sep 10;37(10):192. Epub 2020 Sep 10.

Department of Pharmaceutical Sciences, University of Maryland School of Pharmacy, HSF2 room 623, Baltimore, Maryland, 21201, USA.

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September 2020

Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Moxifloxacin Hydrochloride.

J Pharm Sci 2020 09 12;109(9):2654-2675. Epub 2020 Jun 12.

Fraunhofer IME & Institute of Pharmaceutical Technology, Johann Wolfgang Goethe University, Frankfurt am Main, Germany. Electronic address:

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September 2020

Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Cephalexin Monohydrate.

J Pharm Sci 2020 06 30;109(6):1846-1862. Epub 2020 Mar 30.

Institute of Pharmaceutical Technology, Goethe University, Frankfurt am Main, Germany; Fraunhofer IME, Frankfurt, Germany. Electronic address:

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June 2020

Lack of Association of Generic Brittle Status with Genetics and Physiologic Measures in Patients with Epilepsy.

Pharm Res 2020 Feb 26;37(3):60. Epub 2020 Feb 26.

Department of Pharmaceutical Sciences, University of Maryland, 20 Penn Street, Baltimore, Maryland, 21201, USA.

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February 2020

Relationship of antiepileptic drugs to generic brittleness in patients with epilepsy.

Epilepsy Behav 2020 04 21;105:106936. Epub 2020 Feb 21.

University of Maryland, Department of Pharmaceutical Sciences, 20 Penn Street, Baltimore, MD 21201, USA. Electronic address:

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April 2020

Utility of Films to Anticipate Effect of Drug Load and Polymer on Dissolution Performance from Tablets of Amorphous Itraconazole Spray-Dried Dispersions.

AAPS PharmSciTech 2019 Nov 1;20(8):331. Epub 2019 Nov 1.

Department of Pharmaceutical Sciences, University of Maryland School of Pharmacy, Baltimore, Maryland, 21201, USA.

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November 2019

Fast liquid chromatography-tandem mass spectrometry method for simultaneous determination of eight antiepileptic drugs and an active metabolite in human plasma using polarity switching and timed selected reaction monitoring.

J Pharm Biomed Anal 2019 Nov 17;176:112816. Epub 2019 Aug 17.

Department of Pharmaceutical Sciences, University of Maryland School of Pharmacy, 20 N. Pine Street, Baltimore, MD, 21201, United States. Electronic address:

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November 2019

Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Ondansetron.

J Pharm Sci 2019 10 8;108(10):3157-3168. Epub 2019 Jun 8.

Institute of Pharmaceutical Technology, Johann Wolfgang Goethe University, Frankfurt am Main, Germany. Electronic address:

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October 2019

Pig-a gene mutation database.

Environ Mol Mutagen 2019 10 7;60(8):759-762. Epub 2019 Jun 7.

Division of Genetic and Molecular Toxicology, National Center for Toxicological Research, US Food and Drug Administration, Jefferson, Arkansas.

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October 2019

Exploring generic brittleness and the demographic factors for its susceptibility in patients with epilepsy.

Epilepsy Behav 2019 01 20;90:197-203. Epub 2018 Dec 20.

University of Maryland, Department of Pharmaceutical Sciences, 20 Penn Street, Baltimore, MD 21201, USA. Electronic address:

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January 2019

Irinotecan Alters the Disposition of Morphine Via Inhibition of Organic Cation Transporter 1 (OCT1) and 2 (OCT2).

Pharm Res 2018 Oct 25;35(12):243. Epub 2018 Oct 25.

Department of Clinical Pharmacology, Xiangya Hospital, Central South University, 110 Xiangya Road, Changsha, 410078, Hunan, China.

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October 2018

Attenuated Accumulation of Novel Fluorine (F)-Labeled Bile Acid Analogues in Gallbladders of Fibroblast Growth Factor-15 (FGF15)-Deficient Mice.

Mol Pharm 2018 11 3;15(11):4827-4834. Epub 2018 Oct 3.

Department of Pharmaceutical Sciences , University of Maryland School of Pharmacy , Baltimore , Maryland 21201 , United States.

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November 2018

Selective Inhibition on Organic Cation Transporters by Carvedilol Protects Mice from Cisplatin-Induced Nephrotoxicity.

Pharm Res 2018 Sep 6;35(11):204. Epub 2018 Sep 6.

Department of Pharmaceutical Sciences, School of Pharmacy, University of Maryland at Baltimore, 20 Penn Street, Pharmacy Hall N519, Baltimore, MD, 21201, USA.

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September 2018

Authorized Generic Drugs: an Overview.

AAPS PharmSciTech 2018 Aug 25;19(6):2450-2458. Epub 2018 Jun 25.

Department of Pharmaceutical Sciences, University of Maryland, 20 Penn Street, Baltimore, Maryland, 21201, USA.

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August 2018

Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Proguanil Hydrochloride.

J Pharm Sci 2018 07 20;107(7):1761-1772. Epub 2018 Mar 20.

Institute of Pharmaceutical Technology, Goethe University, Frankfurt am Main, Germany. Electronic address:

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July 2018

Indinavir Alters the Pharmacokinetics of Lamivudine Partially via Inhibition of Multidrug and Toxin Extrusion Protein 1 (MATE1).

Pharm Res 2018 01 4;35(1):14. Epub 2018 Jan 4.

Department of Clinical Pharmacology, Xiangya Hospital, Central South University, 110 Xiangya Road, Changsha, 410078, China.

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January 2018

Equivalence and regulatory approaches of nonbiological complex drug products across the United States, the European Union, and Turkey.

Ann N Y Acad Sci 2017 11 1;1407(1):26-38. Epub 2017 Nov 1.

Department of Pharmaceutical Sciences, University of Maryland, Baltimore, Maryland.

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November 2017

Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Enalapril.

J Pharm Sci 2017 08 21;106(8):1933-1943. Epub 2017 Apr 21.

Institute of Pharmaceutical Technology, Goethe University, Frankfurt am Main, Germany. Electronic address:

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August 2017

Using Multi-fluorinated Bile Acids and In Vivo Magnetic Resonance Imaging to Measure Bile Acid Transport.

J Vis Exp 2016 11 27(117). Epub 2016 Nov 27.

Department of Medicine, University of Maryland School of Medicine; VA Maryland Health Care System;

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November 2016

Multidrug and toxin extrusion proteins mediate cellular transport of cadmium.

Toxicol Appl Pharmacol 2017 Jan 18;314:55-62. Epub 2016 Nov 18.

Department of Pharmaceutical Sciences, School of Pharmacy, University of Maryland at Baltimore, MD, USA. Electronic address:

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January 2017