James E. Polli

United States

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Articles (30)

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2025

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2022

Collaborators (7)

Andrew Hooker

Professor of Pharmacometrics

Uppsala University

SWEDEN

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Hongbing Wang

University of Maryland School of Pharmacy

UNITED STATES

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Parmesh Gajjar

Chief Technology Officer

Infex Therapeutics

UNITED KINGDOM

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Werner Weitschies

Professor of Biopharmaceutics

University of Greifswald

GERMANY

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Melissa Metry

University of Maryland

UNITED STATES

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Jogarao Gobburu

Professor

University of Maryland

UNITED STATES

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Stephen W. Hoag

Professor

University of Maryland

UNITED STATES

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James E. Polli

Research Interests

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Articles (30)

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

Clinical Pharmacology Guidances Advancing Drug Development and Regulatory Assessment: Role and Opportunities

Formulation optimization of ritonavir tablets containing spray dried dispersion from HPMCAS-L or PVP-VA and comparative dissolution/permeation performance

ASSESSMENT OF BIORELEVANT MEDIA TO ANTICIPATE FOOD EFFECT OF ORAL RITONAVIR AMORPHOUS SOLID DISPERSIONS

Introducing the Molecular Pharmaceutics Special Issue on the 2023 PBBM Workshop for Drug Product Quality

Prediction of surfactant-mediated dissolution of poorly soluble drugs from drug powder

In Vitro-In Vivo Correlation Of Amorphous Solid Dispersion Enabled Itraconazole Tablets

Biowaiver monographs for immediate-release solid oral dosage forms: Lemborexant

Impact of drug incorporation into micelle on reduced griseofulvin and meloxicam permeation across a hollow fiber membrane

Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Fexofenadine

In Vitro Lipolysis Model to Predict Food Effect of Poorly Water-Soluble Drugs Itraconazole, Rivaroxaban, and Ritonavir

Lack of Effect of Antioxidants on Biopharmaceutics Classification System (BCS) Class III Drug Permeability

Enteric-Coated Capsules Providing Reliable Site-Specific Drug Delivery to the Distal Ileum

Relative Performance of Volume of Distribution Prediction Methods for Lipophilic Drugs with Uncertainty in LogP Value

Application of bootstrap f to dissolution data from biorelevant media and evidence of the conservative nature of bootstrap f

Efficiency of single pharmaceutical surfactants to mimic intestinal biorelevant media solubilization and dissolution of etravirine: Comparison of intrinsic and film dissolution models

Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Isavuconazonium Sulfate

Prediction of Successful Amorphous Solid Dispersion Pairs through Liquid State Nuclear Magnetic Resonance

Establishing the suitability of model‐integrated evidence to demonstrate bioequivalence for long‐acting injectable and implantable drug products: Summary of workshop

A robust, viable, and resource sparing HPLC-based logP method applied to common drugs

Regulatory utility of mechanistic modeling to support alternative bioequivalence approaches: A workshop overview

Biowaiver Monograph for Immediate-Release Dosage Forms: Levamisole Hydrochloride

Dissolution-Hollow Fiber Membrane (D-HFM) System to Anticipate Biopharmaceutics Risk of Tablets and Capsules

Novel nitroxide-bile acid conjugates inform substrate requirements for human bile acid transporters

A Simple One-Parameter Percent Dissolved Versus Time Dissolution Equation that Accommodates Sink and Non-sink Conditions via Drug Solubility and Dissolution Volume

Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Levocetirizine Dihydrochloride

Drug Permeability - Best Practices for Biopharmaceutics Classification System (BCS)-Based Biowaivers: A workshop Summary Report

FDA/M-CERSI Co-Processed API Workshop Proceedings

Virtual Issue Honoring Gordon L. Amidon: First Editor-in-Chief of Molecular Pharmaceutics

Differential effects of metformin‐mediated <scp>BSEP</scp> repression on pravastatin and bile acid pharmacokinetics in humans: A randomized controlled trial

Collaborators (7)

Andrew Hooker

Hongbing Wang

Parmesh Gajjar

Werner Weitschies

Melissa Metry

Jogarao Gobburu

Stephen W. Hoag

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