Physiologically Based Pharmacokinetic Model Qualification and Reporting Procedures for Regulatory Submissions: A Consortium Perspective
Shebley, Mohamad, Sandhu, Punam, Emami Riedmaier, Arian, Jamei, Masoud, Narayanan, Rangaraj, Patel, Aarti, Peters, Sheila Annie, Reddy, Venkatesh Pilla, Zheng, Ming, Zwart, Loeckie, Beneton, Maud, Bouzom, Francois, Chen, Jun, Chen, Yuan, Cleary, Yumi, Collins, Christiane, Dickinson, Gemma L., Djebli, Nassim, Einolf, Heidi J., Gardner, Iain, Huth, Felix, Kazmi, Faraz, Khalil, Feras, Lin, Jing, Odinecs, Aleksandrs, Patel, Chirag, Rong, Haojing, Schuck, Edgar, Sharma, Pradeep, Wu, Shu‐Pei, Xu, Yang, Yamazaki, Shinji, Yoshida, Kenta, Rowland, Malcolm
Published in Clinical pharmacology and therapeutics (01.07.2018)
Published in Clinical pharmacology and therapeutics (01.07.2018)
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Journal Article
Physiologically‐Based Pharmacokinetic Modeling in Renal and Hepatic Impairment Populations: A Pharmaceutical Industry Perspective
Heimbach, Tycho, Chen, Yuan, Chen, Jun, Dixit, Vaishali, Parrott, Neil, Peters, Sheila Annie, Poggesi, Italo, Sharma, Pradeep, Snoeys, Jan, Shebley, Mohamad, Tai, Guoying, Tse, Susanna, Upreti, Vijay V., Wang, Ying‐Hong, Tsai, Alice, Xia, Binfeng, Zheng, Ming, Zhu, Andy Z.X., Hall, Stephen
Published in Clinical pharmacology and therapeutics (01.08.2021)
Published in Clinical pharmacology and therapeutics (01.08.2021)
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Journal Article
Ubrogepant: Mechanism of action, clinical and translational science
Boinpally, Ramesh, Shebley, Mohamad, Trugman, Joel
Published in Clinical and translational science (01.01.2024)
Published in Clinical and translational science (01.01.2024)
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Journal Article
Atogepant: Mechanism of action, clinical and translational science
Boinpally, Ramesh, Shebley, Mohamad, Trugman, Joel M.
Published in Clinical and translational science (01.01.2024)
Published in Clinical and translational science (01.01.2024)
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Journal Article
Mechanistic Modeling of Intra‐Tumor Spatial Distribution of Antibody‐Drug Conjugates: Insights into Dosing Strategies in Oncology
Weddell, Jared, Chiney, Manoj S., Bhatnagar, Sumit, Gibbs, John P., Shebley, Mohamad
Published in Clinical and translational science (01.01.2021)
Published in Clinical and translational science (01.01.2021)
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Journal Article
Integrating real‐world data and modeling to project changes in femoral neck bone mineral density and fracture risk in premenopausal women
Beck, Denise, Winzenborg, Insa, Gao, Wei, Mostafa, Nael M., Noertersheuser, Peter, Chiuve, Stephanie E., Owens, Charlotte, Shebley, Mohamad
Published in Clinical and translational science (01.07.2021)
Published in Clinical and translational science (01.07.2021)
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Journal Article
Validation of a quantitative systems pharmacology model of calcium homeostasis using elagolix Phase 3 clinical trial data in women with endometriosis
Stodtmann, Sven, Nader, Ahmed, Polepally, Akshanth R., Suleiman, Ahmed A., Winzenborg, Insa, Noertersheuser, Peter, Ng, Juki, Mostafa, Nael M., Shebley, Mohamad
Published in Clinical and translational science (01.07.2021)
Published in Clinical and translational science (01.07.2021)
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Journal Article
Synthesis and Pharmacology of (Pyridin-2-yl)methanol Derivatives as Novel and Selective Transient Receptor Potential Vanilloid 3 Antagonists
Gomtsyan, Arthur, Schmidt, Robert G, Bayburt, Erol K, Gfesser, Gregory A, Voight, Eric A, Daanen, Jerome F, Schmidt, Diana L, Cowart, Marlon D, Liu, Huaqing, Altenbach, Robert J, Kort, Michael E, Clapham, Bruce, Cox, Phil B, Shrestha, Anurupa, Henry, Rodger, Whittern, David N, Reilly, Regina M, Puttfarcken, Pamela S, Brederson, Jill-Desiree, Song, Ping, Li, Bin, Huang, Susan M, McDonald, Heath A, Neelands, Torben R, McGaraughty, Steve P, Gauvin, Donna M, Joshi, Shailen K, Banfor, Patricia N, Segreti, Jason A, Shebley, Mohamad, Faltynek, Connie R, Dart, Michael J, Kym, Philip R
Published in Journal of medicinal chemistry (26.05.2016)
Published in Journal of medicinal chemistry (26.05.2016)
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Journal Article
Phase 2, double-blind, randomized, placebo-controlled study of the safety and efficacy of elagolix in women with polycystic ovary syndrome
Snabes, Michael C., Ng, Juki, Li, Hong, Ali, Izna, Shebley, Mohamad, Schlaff, William D.
Published in F&S Reports (Online) (01.06.2023)
Published in F&S Reports (Online) (01.06.2023)
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Journal Article
Phase 1 study of safety, pharmacokinetics, and antiviral activity of SARS‐CoV‐2 neutralizing monoclonal antibody ABBV‐47D11 in patients with COVID‐19
Shebley, Mohamad, Wang, Stanley, Ali, Izna, Krishnan, Preethi, Tripathi, Rakesh, Reardon, Joseph M., Cafardi, John, Rahav, Galia, Caraco, Yoseph, Slim, Jihad, Al Akhrass, Fadi, Yu, Mengjia, Hu, Yiran, Ferreira, Rosa De Abreu, Alami, Negar N.
Published in Pharmacology research & perspectives (01.02.2023)
Published in Pharmacology research & perspectives (01.02.2023)
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Journal Article
In vitro characterization of drug metabolizing enzymes and transporters to enable a mechanistic drug-drug interaction assessment for venetoclax
Kikuchi, Ryota, Shebley, Mohamad, Bow, Daniel A.J., Carr, Robert A., Nijsen, Marjoleen, de Morais, Sonia M.
Published in Drug metabolism and pharmacokinetics (01.01.2017)
Published in Drug metabolism and pharmacokinetics (01.01.2017)
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SELECTIVE PATHWAYS FOR THE METABOLISM OF PHENCYCLIDINE BY CYTOCHROME P450 2B ENZYMES: IDENTIFICATION OF ELECTROPHILIC METABOLITES, GLUTATHIONE, AND N-ACETYL CYSTEINE ADDUCTS
SHEBLEY, Mohamad, JUSHCHYSHYN, Monica I, HOLLENBERG, Paul F
Published in Drug metabolism and disposition (01.03.2006)
Published in Drug metabolism and disposition (01.03.2006)
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Journal Article
Mechanistic Analysis of the Inactivation of Cytochrome P450 2B6 by Phencyclidine: Effects on Substrate Binding, Electron Transfer, and Uncoupling
SHEBLEY, Mohamad, KENT, Ute M, BALLOU, David P, HOLLENBERG, Paul F
Published in Drug metabolism and disposition (01.04.2009)
Published in Drug metabolism and disposition (01.04.2009)
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Journal Article
Quantitative Prediction of the Effect of CYP3A Inhibitors and Inducers on Venetoclax Pharmacokinetics Using a Physiologically Based Pharmacokinetic Model
Freise, Kevin J, Shebley, Mohamad, Salem, Ahmed Hamed
Published in Journal of clinical pharmacology (01.06.2017)
Published in Journal of clinical pharmacology (01.06.2017)
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