Publications by authors named "Mark Rogge"

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Quantifying clinical and genetic factors influencing rate and severity of autosomal dominant tubulointerstitial kidney disease progression.
Shyam S Ramesh, Mark Rogge, Kendrah O Kidd, Adrienne H Williams, Deok Yong Yoon

J Pharmacokinet Pharmacodyn· July 2025

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Sentinel Dosing-Time for a Risk-Based Approach?
Peter L Bonate, Mark Rogge, Jean-Michel Gries, Alexander J Prokopienko, Sudhakar M Pai

J Clin Pharmacol· March 2025

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Modeling serum M-protein response for early detection of biochemical relapse in myeloma patients treated with bortezomib, lenalidomide and dexamethasone.
Yuki Otani, Yunqi Zhao, Guanyu Wang, Richard Labotka, Mark Rogge

CPT Pharmacometrics Syst Pharmacol· December 2024

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Asia-Inclusive Clinical Research and Development Enabled by Translational Science and Quantitative Clinical Pharmacology: Toward a Culture That Challenges the Status Quo.
Karthik Venkatakrishnan, Neeraj Gupta, Patrick F Smith, Tiffany Lin, Neil Lineberry, Mark Rogge

Clin Pharmacol Ther· February 2023

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Drug Lawsuit Advertisements and the Importance of Physician Consultation Prior to Voluntary Medication Withdrawal or Transition.
Kenneth T Moore, Sudhakar M Pai, Mark Rogge,

J Clin Pharmacol· December 2022

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Applications of Quantitative System Pharmacology Modeling to Model-Informed Drug Development.
Andy Z X Zhu, Mark Rogge

Methods Mol Biol· April 2022

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Regulation of Dietary Supplements and Nutraceutical Products in the United States: An Argument for Greater Oversight and Uniform Standards.
Oliver Grundmann, Parag Kumar, Mark Rogge,

J Clin Pharmacol· January 2022

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Front-Line Health Care Professionals Lack Critical Knowledge in Dietary Supplement and Nutraceutical Products: A Call to Action for Comprehensive Educational Opportunities.
Mark Rogge, Parag Kumar, Oliver Grundmann,

J Clin Pharmacol· January 2022

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Strategies and Recommendations for Using a Data-Driven and Risk-Based Approach in the Selection of First-in-Human Starting Dose: An International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) Assessment.
Michael W Leach, David O Clarke, Sherri Dudal, Chao Han, Chunze Li, Mark C Rogge

Clin Pharmacol Ther· June 2021

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FDA-Industry Scientific Exchange on assessing quantitative systems pharmacology models in clinical drug development: a meeting report, summary of challenges/gaps, and future perspective.
Jane P F Bai, Brian J Schmidt, Kapil G Gadkar, Valeriu Damian, Justin C Earp, Mark Rogge

AAPS J· April 2021

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Science and Evidence-Based Review and Approval of COVID-19 Vaccines: A Statement of Support for the US FDA.
Sudhakar M Pai, Ahmed A Othman, Lorraine Rusch, Joanna C Masters, Douglas Greene, Mark Rogge

J Clin Pharmacol· March 2021

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A quantitative systems pharmacology model of colonic motility with applications in drug development.
Raibatak Das, Lucia Wille, Liming Zhang, Chunlin Chen, Wendy Winchester, Mark Rogge

J Pharmacokinet Pharmacodyn· October 2019

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Targeting RNA: A Transformative Therapeutic Strategy.
Wei Yin, Mark Rogge

Clin Transl Sci· March 2019

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A Semi-Mechanistic Population Pharmacokinetic Model of Nusinersen: An Antisense Oligonucleotide for the Treatment of Spinal Muscular Atrophy.
Konstantinos Biliouris, Puneet Gaitonde, Wei Yin, Daniel A Norris, Yanfeng Wang, Mark Rogge

CPT Pharmacometrics Syst Pharmacol· September 2018

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Population pharmacokinetics of recombinant factor VIII Fc fusion protein.
Ivan Nestorov, Srividya Neelakantan, Thomas M Ludden, Shuanglian Li, Haiyan Jiang, Mark Rogge

Clin Pharmacol Drug Dev· January 2018

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Best practices for the use of itraconazole as a replacement for ketoconazole in drug-drug interaction studies.
Lichuan Liu, Akintunde Bello, Mark J Dresser, Donald Heald, Steven Ferenc Komjathy, Mark Rogge

J Clin Pharmacol· February 2016

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Clinical pharmacology, creating current and future success in drug development.
Mark C Rogge, Mark Dresser, Michael Fossler, Donald Heald, S Aubrey Stoch

J Clin Pharmacol· November 2015

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Pharmacokinetics of renally excreted drug dexpramipexole in subjects with impaired renal function.
Ping He, Doug Kerr, Thomas Marbury, Daniel Ries, Wildon Farwell, Mark Rogge

J Clin Pharmacol· December 2014

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Interferon beta assessment in non-Chinese and Chinese subjects: pharmacokinetics and pharmacodynamic activity of an endogenous cytokine are not race dependent.
Mark C Rogge, Yun Liu, Gerald R Galluppi

J Clin Pharmacol· October 2014

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Nonclinical development of a biosimilar: the current landscape.
Anita O'Connor, Mark Rogge

Bioanalysis· March 2013

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Storm forecasting: additional lessons from the CD28 superagonist TGN1412 trial.
Christopher Horvath, Laura Andrews, Andreas Baumann, Lauren Black, Diann Blanset, Mark Rogge

Nat Rev Immunol· October 2012

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A novel PEGylated interferon beta-1a for multiple sclerosis: safety, pharmacology, and biology.
Xiao Hu, Larisa Miller, Sandra Richman, Stacy Hitchman, Gabrielle Glick, Mark Rogge

J Clin Pharmacol· June 2012

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Clinical pharmacokinetics of tonapofylline: evaluation of dose proportionality, oral bioavailability, and gender and food effects in healthy human subjects.
Zhaoyang Li, Christopher TenHoor, Thomas Marbury, Suzanne Swan, Barry Ticho, Mark Rogge

J Clin Pharmacol· July 2011

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Reply: To PMID 19798640.
James Woodworth, Meena Subramanyam, Mark Rogge

Ann Neurol· February 2010

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Safety, pharmacokinetics and pharmacodynamics of atacicept in healthy volunteers.
Alain Munafo, Anthony Priestley, Ivan Nestorov, Jennifer Visich, Mark Rogge

Eur J Clin Pharmacol· July 2007

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