James E Polli (James Polli)

Publication Activity (10 Years)

Years Active: 2018-2024
Publications (10 Years): 32

Top Topics

Iron Deficiency

Clostridium Difficile

Psychometric Properties

Top Venues

Molecular pharmaceutics

CPT: pharmacometrics & systems pharmacology

Pharmaceutical research

Clinical and translational science

This page only lists publications with an associated author ORCID identifier.

Publications

Ana L Coutinho, Rodrigo Cristofoletti, Fang Wu, Abdullah Al Shoyaib, Jennifer Dressman, James E Polli
Relative Performance of Volume of Distribution Prediction Methods for Lipophilic Drugs with Uncertainty in LogP Value. Pharmaceutical research 41 (6) (2024)
Xavier J H Pepin, Sumit Arora, Luiza Borges, Mario Cano-Vega, Tessa Carducci, Parnali Chatterjee, Grace Chen, Rodrigo Cristofoletti, André Dallmann, Poonam Delvadia, Jennifer Dressman, Nikoletta Fotaki, Elizabeth Gray, Tycho Heimbach, Øyvind Holte, Shinichi Kijima, Evangelos Kotzagiorgis, Hans Lennernäs, Anders Lindahl, Raimar Loebenberg, Claire Mackie, Maria Malamatari, Mark McAllister, Amitava Mitra, Rebecca Moody, Deanna M Mudie, Flora Musuamba Tshinanu, James E Polli, Bhagwant Rege, Xiaojun Ren, Gregory Rullo, Megerle Scherholz, Ivy Song, Cordula Stillhart, Sandra Suarez-Sharp, Christer Tannergren, Eleftheria Tsakalozou, Shereeni Veerasingham, Christian Wagner, Paul Seo
Parameterization of Physiologically Based Biopharmaceutics Models: Workshop Summary Report. Molecular pharmaceutics (2024)
Ana L Coutinho, Rodrigo Cristofoletti, Fang Wu, Abdullah Al Shoyaib, Jennifer Dressman, James E Polli
Relative Performance of Volume of Distribution Prediction Methods for Lipophilic Drugs with Uncertainty in LogP Value. Pharmaceutical research 41 (6) (2024)
Xavier J H Pepin, Sumit Arora, Luiza Borges, Mario Cano-Vega, Tessa Carducci, Parnali Chatterjee, Grace Chen, Rodrigo Cristofoletti, André Dallmann, Poonam Delvadia, Jennifer Dressman, Nikoletta Fotaki, Elizabeth Gray, Tycho Heimbach, Øyvind Holte, Shinichi Kijima, Evangelos Kotzagiorgis, Hans Lennernäs, Anders Lindahl, Raimar Loebenberg, Claire Mackie, Maria Malamatari, Mark McAllister, Amitava Mitra, Rebecca Moody, Deanna M Mudie, Flora Musuamba Tshinanu, James E Polli, Bhagwant Rege, Xiaojun Ren, Gregory Rullo, Megerle Scherholz, Ivy Song, Cordula Stillhart, Sandra Suarez-Sharp, Christer Tannergren, Eleftheria Tsakalozou, Shereeni Veerasingham, Christian Wagner, Paul Seo
Parameterization of Physiologically Based Biopharmaceutics Models: Workshop Summary Report. Molecular pharmaceutics 21 (8) (2024)
Claire Mackie, Sumit Arora, Paul Seo, Rebecca Moody, Bhagwant Rege, Xavier J H Pepin, Tycho Heimbach, Christer Tannergren, Amitava Mitra, Sandra Suarez-Sharp, Luiza Novaes Borges, Shinichi Kijima, Evangelos Kotzagiorgis, Maria Malamatari, Shereeni Veerasingham, James E Polli, Gregory Rullo
Physiologically Based Biopharmaceutics Modeling (PBBM): Best Practices for Drug Product Quality, Regulatory and Industry Perspectives: 2023 Workshop Summary Report. Molecular pharmaceutics (2024)
Michael Grimm, Linus Großmann, Stefan Senekowitsch, Adrian Rump, James E Polli, Jennifer Dressman, Werner Weitschies
Enteric-Coated Capsules Providing Reliable Site-Specific Drug Delivery to the Distal Ileum. Molecular pharmaceutics (2024)
Ana L Coutinho, Rodrigo Cristofoletti, Fang Wu, Abdullah Al Shoyaib, Jennifer Dressman, James E Polli
Relative Performance of Volume of Distribution Prediction Methods for Lipophilic Drugs with Uncertainty in LogP Value. Pharmaceutical research (2024)
Ana L Coutinho, Rodrigo Cristofoletti, Fang Wu, Abdullah Al Shoyaib, Jennifer Dressman, James E Polli
Relative Performance of Volume of Distribution Prediction Methods for Lipophilic Drugs with Uncertainty in LogP Value. Pharmaceutical research 41 (6) (2024)
Michael Grimm, Linus Großmann, Stefan Senekowitsch, Adrian Rump, James E Polli, Jennifer Dressman, Werner Weitschies
Enteric-Coated Capsules Providing Reliable Site-Specific Drug Delivery to the Distal Ileum. Molecular pharmaceutics 21 (6) (2024)
Claire Mackie, Sumit Arora, Paul Seo, Rebecca Moody, Bhagwant Rege, Xavier J H Pepin, Tycho Heimbach, Christer Tannergren, Amitava Mitra, Sandra Suarez-Sharp, Luiza Novaes Borges, Shinichi Kijima, Evangelos Kotzagiorgis, Maria Malamatari, Shereeni Veerasingham, James E Polli, Gregory Rullo
Physiologically Based Biopharmaceutics Modeling (PBBM): Best Practices for Drug Product Quality, Regulatory and Industry Perspectives: 2023 Workshop Summary Report. Molecular pharmaceutics 21 (5) (2024)
Claire Mackie, Sumit Arora, Paul Seo, Rebecca Moody, Bhagwant Rege, Xavier J H Pepin, Tycho Heimbach, Christer Tannergren, Amitava Mitra, Sandra Suarez-Sharp, Luiza Novaes Borges, Shinichi Kijima, Evangelos Kotzagiorgis, Maria Malamatari, Shereeni Veerasingham, James E Polli, Gregory Rullo
Physiologically Based Biopharmaceutics Modeling (PBBM): Best Practices for Drug Product Quality, Regulatory and Industry Perspectives: 2023 Workshop Summary Report. Molecular pharmaceutics 21 (5) (2024)
Claire Mackie, Sumit Arora, Paul Seo, Rebecca Moody, Bhagwant Rege, Xavier J H Pepin, Tycho Heimbach, Christer Tannergren, Amitava Mitra, Sandra Suarez-Sharp, Luiza Novaes Borges, Shinichi Kijima, Evangelos Kotzagiorgis, Maria Malamatari, Shereeni Veerasingham, James E Polli, Gregory Rullo
Physiologically Based Biopharmaceutics Modeling (PBBM): Best Practices for Drug Product Quality, Regulatory and Industry Perspectives: 2023 Workshop Summary Report. Molecular pharmaceutics 21 (5) (2024)
Michael Grimm, Linus Großmann, Stefan Senekowitsch, Adrian Rump, James E Polli, Jennifer Dressman, Werner Weitschies
Enteric-Coated Capsules Providing Reliable Site-Specific Drug Delivery to the Distal Ileum. Molecular pharmaceutics 21 (6) (2024)
Claire Mackie, Sumit Arora, Paul Seo, Rebecca Moody, Bhagwant Rege, Xavier J H Pepin, Tycho Heimbach, Christer Tannergren, Amitava Mitra, Sandra Suarez-Sharp, Luiza Novaes Borges, Shinichi Kijima, Evangelos Kotzagiorgis, Maria Malamatari, Shereeni Veerasingham, James E Polli, Gregory Rullo
Physiologically Based Biopharmaceutics Modeling (PBBM): Best Practices for Drug Product Quality, Regulatory and Industry Perspectives: 2023 Workshop Summary Report. Molecular pharmaceutics 21 (5) (2024)
Xavier J H Pepin, Sumit Arora, Luiza Borges, Mario Cano-Vega, Tessa Carducci, Parnali Chatterjee, Grace Chen, Rodrigo Cristofoletti, André Dallmann, Poonam Delvadia, Jennifer Dressman, Nikoletta Fotaki, Elizabeth Gray, Tycho Heimbach, Øyvind Holte, Shinichi Kijima, Evangelos Kotzagiorgis, Hans Lennernäs, Anders Lindahl, Raimar Loebenberg, Claire Mackie, Maria Malamatari, Mark McAllister, Amitava Mitra, Rebecca Moody, Deanna M Mudie, Flora Musuamba Tshinanu, James E Polli, Bhagwant Rege, Xiaojun Ren, Gregory Rullo, Megerle Scherholz, Ivy Song, Cordula Stillhart, Sandra Suarez-Sharp, Christer Tannergren, Eleftheria Tsakalozou, Shereeni Veerasingham, Christian Wagner, Paul Seo
Parameterization of Physiologically Based Biopharmaceutics Models: Workshop Summary Report. Molecular pharmaceutics 21 (8) (2024)
Xavier J H Pepin, Sumit Arora, Luiza Borges, Mario Cano-Vega, Tessa Carducci, Parnali Chatterjee, Grace Chen, Rodrigo Cristofoletti, André Dallmann, Poonam Delvadia, Jennifer Dressman, Nikoletta Fotaki, Elizabeth Gray, Tycho Heimbach, Øyvind Holte, Shinichi Kijima, Evangelos Kotzagiorgis, Hans Lennernäs, Anders Lindahl, Raimar Loebenberg, Claire Mackie, Maria Malamatari, Mark McAllister, Amitava Mitra, Rebecca Moody, Deanna M Mudie, Flora Musuamba Tshinanu, James E Polli, Bhagwant Rege, Xiaojun Ren, Gregory Rullo, Megerle Scherholz, Ivy Song, Cordula Stillhart, Sandra Suarez-Sharp, Christer Tannergren, Eleftheria Tsakalozou, Shereeni Veerasingham, Christian Wagner, Paul Seo
Parameterization of Physiologically Based Biopharmaceutics Models: Workshop Summary Report. Molecular pharmaceutics 21 (8) (2024)
Andrew Babiskin, Fang Wu, Youssef Mousa, Ming-Liang Tan, Eleftheria Tsakalozou, Ross L Walenga, Miyoung Yoon, Sam G Raney, James E Polli, Anna Schwendeman, Vishalakshi Krishnan, Lanyan Fang, Liang Zhao
Regulatory utility of mechanistic modeling to support alternative bioequivalence approaches: A workshop overview. CPT: pharmacometrics & systems pharmacology (2023)
Yuqing Gong, Peijue Zhang, Miyoung Yoon, Hao Zhu, Ameya Kohojkar, Andrew C Hooker, Murray P Ducharme, Jogarao V S Gobburu, Géraldine Cellière, Parmesh Gajjar, Bing V Li, Raja Velagapudi, Yu Chung Tsang, Anna Schwendeman, James E Polli, Lanyan Fang, Robert Lionberger, Liang Zhao
Establishing the Suitability of Model-Integrated Evidence to Demonstrate Bioequivalence for Long-Acting Injectable and Implantable Drug Products: Summary of Workshop. CPT: pharmacometrics & systems pharmacology (2023)
James E Polli
Virtual Issue Honoring Gordon L. Amidon: First Editor-in-Chief of Molecular Pharmaceutics . Molecular pharmaceutics 20 (11) (2023)
Mirko Koziolek, Patrick Augustijns, Constantin Berger, Rodrigo Cristofoletti, David Dahlgren, Janneke Keemink, Pär Matsson, Fiona McCartney, Marco Metzger, Mario Mezler, Janis Niessen, James E Polli, Maria Vertzoni, Werner Weitschies, Jennifer Dressman
Challenges in Permeability Assessment for Oral Drug Product Development. Pharmaceutics 15 (10) (2023)
Yuqing Gong, Peijue Zhang, Miyoung Yoon, Hao Zhu, Ameya Kohojkar, Andrew C Hooker, Murray P Ducharme, Jogarao V S Gobburu, Géraldine Cellière, Parmesh Gajjar, Bing V Li, Raja Velagapudi, Yu Chung Tsang, Anna Schwendeman, James E Polli, Lanyan Fang, Robert Lionberger, Liang Zhao
Establishing the suitability of model-integrated evidence to demonstrate bioequivalence for long-acting injectable and implantable drug products: Summary of workshop. CPT: pharmacometrics & systems pharmacology (2023)
Andrew Babiskin, Fang Wu, Youssef Mousa, Ming-Liang Tan, Eleftheria Tsakalozou, Ross L Walenga, Miyoung Yoon, Sam G Raney, James E Polli, Anna Schwendeman, Vishalakshi Krishnan, Lanyan Fang, Liang Zhao
Regulatory Utility of Mechanistic Modeling to Support Alternative Bioequivalence Approaches: A Workshop Overview. CPT: pharmacometrics & systems pharmacology (2023)
Melissa Metry, Samuel A Krug, Vijaya Kumari Karra, Maureen A Kane, Jeffrey C Fink, Yan Shu, Hongbing Wang, James E Polli
Differential effects of metformin-mediated BSEP repression on pravastatin and bile acid pharmacokinetics in humans: A randomized controlled trial. Clinical and translational science 15 (10) (2022)
Fang Wu, Youssef Mousa, Kimberly Raines, Chris Bode, Yu Chung Tsang, Rodrigo Cristofoletti, Hongling Zhang, Tycho Heimbach, Lanyan Fang, Filippos Kesisoglou, Amitava Mitra, James E Polli, Myong-Jin Kim, Jianghong Fan, Banu S Zolnik, Duxin Sun, Yi Zhang, Liang Zhao
Regulatory Utility of Physiologically Based Pharmacokinetic Modeling to Support Alternative Bioequivalence Approaches and Risk Assessment: A Workshop Summary Report. CPT: pharmacometrics & systems pharmacology (2022)
Fang Wu, Youssef Mousa, Kimberly Raines, Chris Bode, Yu Chung Tsang, Rodrigo Cristofoletti, Hongling Zhang, Tycho Heimbach, Lanyan Fang, Filippos Kesisoglou, Amitava Mitra, James E Polli, Myong-Jin Kim, Jianghong Fan, Banu S Zolnik, Duxin Sun, Yi Zhang, Liang Zhao
Regulatory utility of physiologically-based pharmacokinetic modeling to support alternative bioequivalence approaches and risk assessment: A workshop summary report. CPT: pharmacometrics & systems pharmacology (2022)
Sophie Shubow, Qin Sun, Ai Len Nguyen Phan, Dana C Hammell, Maureen Kane, Gary H Lyman, Allan Gibofsky, Gary R Lichtenstein, Zachary Bloomgarden, Raymond K Cross, Sarah Yim, James E Polli, Yow-Ming C Wang
Prescriber Perspectives on Biosimilar Adoption and Potential Role of Clinical Pharmacology: A Workshop Summary. Clinical pharmacology and therapeutics (2022)
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
Evaluation of the Physicochemical Properties of the Iron Nanoparticle Drug Products: Brand and Generic Sodium Ferric Gluconate. Molecular pharmaceutics 18 (4) (2021)
Sharmila Das, Dong Guo, Xiaohui Jiang, Wenlei Jiang, Yan Shu, Tricia Y Ting, James E Polli
Lack of Association of Generic Brittle Status with Genetics and Physiologic Measures in Patients with Epilepsy. Pharmaceutical research 37 (3) (2020)
Asmita Adhikari, James E Polli
Characterization of Grades of HPMCAS Spray Dried Dispersions of Itraconazole Based on Supersaturation Kinetics and Molecular Interactions Impacting Formulation Performance. Pharmaceutical research 37 (10) (2020)
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
ICH M9 Guideline in Development on Biopharmaceutics Classification System-Based Biowaivers: An Industrial Perspective from the IQ Consortium. Molecular pharmaceutics 17 (2) (2020)
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
Snapshots of Iron Speciation: Tracking the Fate of Iron Nanoparticle Drugs via a Liquid Chromatography-Inductively Coupled Plasma-Mass Spectrometric Approach. Molecular pharmaceutics 16 (3) (2019)
Melissa Metry, Jessica Felton, Kunrong Cheng, Su Xu, Yong Ai, Fengtian Xue, Jean-Pierre Raufman, James E Polli
Attenuated Accumulation of Novel Fluorine (19F)-Labeled Bile Acid Analogues in Gallbladders of Fibroblast Growth Factor-15 (FGF15)-Deficient Mice. Molecular pharmaceutics 15 (11) (2018)