Publications by authors named "Pol Boudes"

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Reply to Comments for 'Appraisal of AI-Based Fibrosis Quantification in MASH'.
Kutbuddin Akbary, Mazen Noureddin, Ren Yayun, Dean Tai, Pol Boudes

Liver Int· October 2025

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Development of AI Based Fibrosis Detection Algorithm by SHG/TPEF Microscopy for Fully Quantified Liver Fibrosis Assessment in MASH.
Kutbuddin Akbary, Mazen Noureddin, Ren Yayun, Dean Tai, Pol Boudes

Liver Int· September 2025

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Seladelpar efficacy and safety at 3 months in patients with primary biliary cholangitis: ENHANCE, a phase 3, randomized, placebo-controlled study.
Gideon M Hirschfield, Mitchell L Shiffman, Aliya Gulamhusein, Kris V Kowdley, John M Vierling, Pol F Boudes

Hepatology· August 2023

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Machine learning liver histology scores correlate with portal hypertension assessments in nonalcoholic steatohepatitis cirrhosis.
Mazen Noureddin, Zachary Goodman, Dean Tai, Elaine L K Chng, Yayun Ren, Pol Boudes

Aliment Pharmacol Ther· February 2023

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A phase II, randomized, open-label, 52-week study of seladelpar in patients with primary biliary cholangitis.
Christopher L Bowlus, Michael R Galambos, Richard J Aspinall, Gideon M Hirschfield, David E J Jones, Pol Boudes

J Hepatol· August 2022

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Seladelpar (MBX-8025), a selective PPAR-δ agonist, in patients with primary biliary cholangitis with an inadequate response to ursodeoxycholic acid: a double-blind, randomised, placebo-controlled, phase 2, proof-of-concept study.
David Jones, Pol F Boudes, Mark G Swain, Christopher L Bowlus, Michael R Galambos

Lancet Gastroenterol Hepatol· October 2017

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Risk Evaluation and Mitigation Strategies (REMSs): Are They Improving Drug Safety? A Critical Review of REMSs Requiring Elements to Assure Safe Use (ETASU).
Pol F Boudes

Drugs R D· June 2017

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Duvoglustat HCl Increases Systemic and Tissue Exposure of Active Acid α-Glucosidase in Pompe Patients Co-administered with Alglucosidase α.
Priya Kishnani, Mark Tarnopolsky, Mark Roberts, Kumarswamy Sivakumar, Majed Dasouki, Pol Boudes

Mol Ther· May 2017

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Oral pharmacological chaperone migalastat compared with enzyme replacement therapy in Fabry disease: 18-month results from the randomised phase III ATTRACT study.
Derralynn A Hughes, Kathleen Nicholls, Suma P Shankar, Gere Sunder-Plassmann, David Koeller, Pol Boudes

J Med Genet· April 2017

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The Pharmacodynamics, Pharmacokinetics, and Safety of Arhalofenate in Combination with Febuxostat When Treating Hyperuricemia Associated with Gout.
Alexandra S Steinberg, Bradley D Vince, Yun-Jung Choi, Robert L Martin, Charles A McWherter, Pol F Boudes

J Rheumatol· March 2017

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A Randomized, Double-Blind, Active- and Placebo-Controlled Efficacy and Safety Study of Arhalofenate for Reducing Flare in Patients With Gout.
Jeffrey Poiley, Alexandra S Steinberg, Yun-Jung Choi, Charles S Davis, Robert L Martin, Pol F Boudes

Arthritis Rheumatol· August 2016

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Oral Migalastat HCl Leads to Greater Systemic Exposure and Tissue Levels of Active α-Galactosidase A in Fabry Patients when Co-Administered with Infused Agalsidase.
David G Warnock, Daniel G Bichet, Myrl Holida, Ozlem Goker-Alpan, Kathy Nicholls, Pol Boudes

PLoS One· May 2016

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An open-label study to determine the pharmacokinetics and safety of migalastat HCl in subjects with impaired renal function and healthy subjects with normal renal function.
Franklin K Johnson, Paul N Mudd, Tara DiMino, Jennie Vosk, Sheela Sitaraman, Pol Boudes

Clin Pharmacol Drug Dev· July 2015

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Clinical studies in lysosomal storage diseases: Past, present, and future.
Pol F Boudes

Rare Dis· July 2014

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Gene therapy as a new treatment option for inherited monogenic diseases.
Pol F Boudes

Eur J Intern Med· January 2014

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Migalastat HCl reduces globotriaosylsphingosine (lyso-Gb3) in Fabry transgenic mice and in the plasma of Fabry patients.
Brandy Young-Gqamana, Nastry Brignol, Hui-Hwa Chang, Richie Khanna, Rebecca Soska, Pol Boudes

PLoS One· December 2013

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Clinical studies in lysosomal storage diseases: past, present and future.
Pol F Boudes

Pediatr Endocrinol Rev· November 2013

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Pharmacokinetics and Safety of Migalastat HCl and Effects on Agalsidase Activity in Healthy Volunteers.
Franklin K Johnson, Paul N Mudd, Alexander Bragat, Mathews Adera, Pol Boudes

Clin Pharmacol Drug Dev· April 2013

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Safety and pharmacodynamic effects of a pharmacological chaperone on α-galactosidase A activity and globotriaosylceramide clearance in Fabry disease: report from two phase 2 clinical studies.
Dominique P Germain, Roberto Giugliani, Derralynn A Hughes, Atul Mehta, Kathy Nicholls, Pol F Boudes

Orphanet J Rare Dis· November 2012

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Novel quantitative method to evaluate globotriaosylceramide inclusions in renal peritubular capillaries by virtual microscopy in patients with fabry disease.
Laura Barisoni, J Charles Jennette, Robert Colvin, Sheela Sitaraman, Alexander Bragat, Pol Boudes

Arch Pathol Lab Med· July 2012

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A pharmacogenetic approach to identify mutant forms of α-galactosidase A that respond to a pharmacological chaperone for Fabry disease.
Xiaoyang Wu, Evan Katz, Maria Cecilia Della Valle, Kirsten Mascioli, John J Flanagan, Pol Boudes

Hum Mutat· August 2011

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An analysis of the impact of FDA's guidelines for addressing cardiovascular risk of drugs for type 2 diabetes on clinical development.
Christopher Viereck, Pol Boudes

Contemp Clin Trials· May 2011

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An analysis of current pharmaceutical industry practices for making clinical trial results publicly accessible.
Christopher Viereck, Pol Boudes

Contemp Clin Trials· July 2009

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The challenges of new drugs benefits and risks analysis: lessons from the ximelagatran FDA Cardiovascular Advisory Committee.
Pol F Boudes

Contemp Clin Trials· October 2006

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