James E Polli

Evaluation of the Physicochemical Properties of the Iron Nanoparticle Drug Products: Brand and Generic Sodium Ferric Gluconate.

Authors:

Joel E P Brandis Kyle C Kihn Marc B Taraban Julia Schnorr Alex M Confer Sharon Batelu Dajun Sun Jason D Rodriguez Wenlei Jiang David P Goldberg Peter Langguth Timothy L Stemmler Yihua Bruce Yu Maureen A Kane James E Polli Sarah L J Michel

Mol Pharm 2021 Feb 23. Epub 2021 Feb 23.

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

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February 2021

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

Authors:

Mauricio A García Rodrigo Cristofoletti Bertil Abrahamsson Dirk W Groot Alan Parr James E Polli Mehul Mehta Vinod P Shah Tajiri Tomakazu Jennifer B Dressman Peter Langguth

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.

Authors:

Melissa Metry Yan Shu Bertil Abrahamsson Rodrigo Cristofoletti Jennifer B Dressman D W Groot Alan Parr Peter Langguth Vinod P Shah Tomokazu Tajiri Mehul U Mehta James E Polli

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

Similarity of dissolution profiles from biorelevant media: Assessment of interday repeatability, interanalyst repeatability, and interlaboratory reproducibility using ibuprofen and ketoconazole tablets.

Authors:

Raqeeb Jamil Ting Xu Harsh S Shah Asmita Adhikari Rusha Sardhara Kajal Nahar Kenneth R Morris James E Polli

Eur J Pharm Sci 2021 Jan 25;156:105573. Epub 2020 Sep 25.

University of Maryland, Department of Pharmaceutical Sciences, 20 Penn Street, Baltimore, MD21201, United States. 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.

Authors:

Moshe Honick Sharmila Das Stephen W Hoag Francis X Muller Alaadin Alayoubi Xin Feng Ahmed Zidan Muhammad Ashraf James E Polli

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.

Authors:

Asmita Adhikari James E Polli

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.

Authors:

Naseem A Charoo Daud B Abdallah Thahera Parveen Bertil Abrahamsson Rodrigo Cristofoletti Dirk W Groot Peter Langguth Alan Parr James E Polli Mehul Mehta Vinod P Shah Tomokazu Tajiri Jennifer Dressman

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.

Authors:

Gerlinde F Plöger Paul M Quizon Bertil Abrahamsson Rodrigo Cristofoletti Dirk W Groot Alan Parr Peter Langguth James E Polli Vinod P Shah Tomokazu Tajiri Mehul U Mehta Jennifer Dressman

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.

Authors:

Sharmila Das Dong Guo Xiaohui Jiang Wenlei Jiang Yan Shu Tricia Y Ting James E Polli

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.

Authors:

Sharmila Das Xiaohui Jiang Wenlei Jiang Tricia Y Ting James E Polli

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

ICH M9 Guideline in Development on Biopharmaceutics Classification System-Based Biowaivers: An Industrial Perspective from the IQ Consortium.

Authors:

Philip Bransford Jack Cook Manish Gupta Sebastian Haertter Handan He Rob Ju Jitendra Kanodia Hans Lennernäs David Lindley James E Polli Larissa Wenning Yunhui Wu

Mol Pharm 2020 02 7;17(2):361-372. Epub 2020 Jan 7.

Pharmaceutical Sciences, MRL , Merck & Co., Inc. , West Point , Pennsylvania 19486 , United States.

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February 2020

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

Authors:

Moshe Honick Kanika Sarpal Alaadin Alayoubi Ahmed Zidan Stephen W Hoag Robert G Hollenbeck Eric J Munson James E Polli

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.

Authors:

Tian Liu Raghavendhar R Kotha Jace W Jones James E Polli Maureen A Kane

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.

Authors:

Gopal Singh Rajawat Tejashree Belubbi Mangal S Nagarsenker Bertil Abrahamsson Rodrigo Cristofoletti Dirk W Groot Peter Langguth Alan Parr James E Polli Mehul Mehta Vinod P Shah Tomokazu Tajiri Jennifer Dressman

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.

Authors:

Jennifer M Shemansky Lea Patrice McDaniel Christopher Klimas Stephen D Dertinger Vasily N Dobrovolsky Takafumi Kimoto Katsuyoshi Horibata James E Polli Robert H Heflich

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

Snapshots of Iron Speciation: Tracking the Fate of Iron Nanoparticle Drugs via a Liquid Chromatography-Inductively Coupled Plasma-Mass Spectrometric Approach.

Authors:

Heather M Neu Sergei A Alexishin Joel E P Brandis Anne M C Williams Wenjing Li Dajun Sun Nan Zheng Wenlei Jiang Ann Zimrin Jeffrey C Fink James E Polli Maureen A Kane Sarah L J Michel

Mol Pharm 2019 03 14;16(3):1272-1281. Epub 2019 Feb 14.

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

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March 2019

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

Authors:

Sharmila Das Xia Pu Xiaohui Jiang Wenlei Jiang Renee Tung Tricia Y Ting James E Polli

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).

Authors:

Peng Zhu Zhi Ye Dong Guo Zongping Xiong Shiqiong Huang Jun Guo Wei Zhang James E Polli Honghao Zhou Qing Li Yan Shu

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.

Authors:

Melissa Metry Jessica Felton Kunrong Cheng Su Xu Yong Ai Fengtian Xue Jean-Pierre Raufman James E Polli

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.

Authors:

Dong Guo Hong Yang Qing Li Hyo Jung Bae Obinna Obianom Sujuan Zeng Tong Su James E Polli Yan Shu

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