Publications by authors named "James Polli"

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Regulatory utility of physiologically-based pharmacokinetic modeling to support alternative bioequivalence approaches and risk assessment: A workshop summary report.
Fang Wu, Youssef Mousa, Kimberly Raines, Chris Bode, Yu Chung Tsang, Rodrigo Cristofoletti, Hongling Zhang, Tycho Heimbach, Lanyan Fang, Filippos Kesisoglou

CPT Pharmacometrics Syst Pharmacol· May 2023

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Comparison of the z-factor and Polli dissolution rate coefficient for monodisperse powders.
Roshni P Patel, James E Polli

Int J Pharm· January 2026

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Biowaiver monograph for immediate-release solid oral dosage forms: Empagliflozin.
Reiji Negoya, Mayuki Tsueoka, Xichen Sun, Shuto Nishida, Bertil Abrahamsson, James E Polli

J Pharm Sci· December 2025

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Formulation optimization of ritonavir tablets containing spray dried dispersion from HPMCAS-L or PVP-VA and comparative dissolution/permeation performance.
Ayse Nur Oktay, James E Polli

Int J Pharm· November 2025

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Biowaiver monograph for immediate-release solid oral dosage forms: Amlodipine besylate.
Porfirio de la Cruz-Cruz, Mauricio A García, José Trinidad Pérez-Urizar, Bertil Abrahamsson, Rodrigo Cristofoletti, James E Polli

J Pharm Sci· November 2025

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Transient pH film model for in vitro powder dissolution of weakly acidic drugs into buffer: Consideration of surface acidification and comparison to conventional film model.
Roshni P Patel, James E Polli

J Pharm Sci· October 2025

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Clinical Pharmacology Guidances Advancing Drug Development and Regulatory Assessment: Role and Opportunities.
Anuradha Ramamoorthy, Daphne Guinn, Elimika Pfuma Fletcher, Michael Pacanowski, Kellie Reynolds, James Polli

J Clin Pharmacol· September 2025

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Comparison of In Vitro and Dissolution of Norvir Oral Powder: Relevance of a too Rapid Dissolution Test.
Ayşe Nur Oktay, James E Polli

Turk J Pharm Sci· September 2025

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Impact of antioxidant addition on drug dissolution: Implications for NDSRI mitigation biowaivers.
Rutu R Valapil, James E Polli

Int J Pharm· August 2025

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A physiologically based biopharmaceutics modeling (PBBM) framework for characterizing formulation-dependent food effects: Paving the road towards fed state virtual BE studies for itraconazole amorphous solid dispersions.
Niklas Rudolph, Nitin Charbe, David Plano, Abdullah Al Shoyaib, Arindom Pal, James Polli

Eur J Pharm Sci· June 2025

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Development of a Physiologically Based Biopharmaceutics Model Report Template: Considerations for Improved Quality in View of Regulatory Submissions.
Sumit Arora, Xavier Pepin, Masoud Jamei, Pradeep Sharma, Tycho Heimbach, James E Polli

Mol Pharm· June 2025

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Introducing the Molecular Pharmaceutics Special Issue on the 2023 PBBM Workshop for Drug Product Quality.
Claire Mackie, Xavier Pepin, Tycho Heimbach, Christer Tannergren, Sumit Arora, James Polli

Mol Pharm· June 2025

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Prediction of surfactant-mediated dissolution of poorly soluble drugs from drug powder.
Roshni P Patel, Erik B Nordquist, James E Polli

Eur J Pharm Sci· May 2025

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Paving the Path for Increased Technological Innovation, Strategic Decision Making and Regulatory Acceptance of Modeling and Simulation Approaches.
Lanyan Fang, Eleftheria Tsakalozou, James E Polli

Pharm Res· May 2025

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In Vitro-In Vivo Correlation Of Amorphous Solid Dispersion Enabled Itraconazole Tablets.
Ana L Coutinho, Asmita Adhikari, Samuel Krug, Maureen Kane, R Gary Hollenbeck, James E Polli

Pharm Res· March 2025

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Biowaiver monographs for immediate-release solid oral dosage forms: Lemborexant.
Kristian Beran, Bertil Abrahamsson, Naseem Charoo, Rodrigo Cristofoletti, René Holm, James E Polli

J Pharm Sci· February 2025

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Biowaiver monographs for immediate-release solid oral dosage forms: Voriconazole.
Kristian Beran, Bertil Abrahamsson, Naseem Charoo, Rodrigo Cristofoletti, René Holm, James E Polli

J Pharm Sci· February 2025

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Impact of drug incorporation into micelle on reduced griseofulvin and meloxicam permeation across a hollow fiber membrane.
Roshni P Patel, Lynne S Taylor, James E Polli

J Pharm Sci· January 2025

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Current State and New Horizons in Applications of Physiologically Based Biopharmaceutics Modeling (PBBM): A Workshop Report.
Christer Tannergren, Sumit Arora, Andrew Babiskin, Luiza Borges, Parnali Chatterjee, James Polli

Mol Pharm· January 2025

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Microscope-enabled disc dissolution system: Concordance between drug and polymer dissolution from an amorphous solid dispersion disc and visual disc degradation.
Shuaiqian Men, James E Polli

J Pharm Sci· December 2024

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Prediction of Successful Amorphous Solid Dispersion Pairs through Liquid State Nuclear Magnetic Resonance.
Ana L Coutinho, Kellie Hom, James E Polli

Mol Pharm· December 2024

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Biowaiver monograph for immediate-release solid oral dosage forms: Raltegravir potassium.
Atsushi Kambayashi, Masaki Iida, Makoto Ishihara, Yoshinori Takahashi, Bertil Abrahamsson, James E Polli

J Pharm Sci· November 2024

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PBBM Considerations for Base Models, Model Validation, and Application Steps: Workshop Summary Report.
Tycho Heimbach, Flora Musuamba Tshinanu, Kimberly Raines, Luiza Borges, Shinichi Kijima, James E Polli

Mol Pharm· November 2024

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Screening of Polymers for Oral Ritonavir Amorphous Solid Dispersions by Film Casting.
Ayse Nur Oktay, James E Polli

Pharmaceutics· October 2024

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Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Fexofenadine.
Naseem A Charoo, N Selvasudha, Zahira Nala Kath, Bertil Abrahamsson, Rodrigo Cristofoletti, James E Polli

J Pharm Sci· September 2024

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Parameterization of Physiologically Based Biopharmaceutics Models: Workshop Summary Report.
Xavier Pepin, Sumit Arora, Luiza Borges, Mario Cano-Vega, Tessa Carducci, James E Polli

Mol Pharm· August 2024

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