Publications by authors named "Nael Mostafa"

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Budigalimab, an anti-PD-1 inhibitor, for people living with HIV-1: a randomized, placebo-controlled phase 1b study.
Moti N Ramgopal, Jacob P Lalezari, Ana Gabriela Pires Dos Santos, Preethi Krishnan, Tanaya R Vaidya, Nael M Mostafa

Nat Med· November 2025

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IQ Survey Results on Current Industry Practices: Part 2-Quantitative Evaluations of Immunogenicity Assessment.
Susan Richards, Insa Winzenborg, Doreen Luedtke, Tao Niu, Lora Hamuro, Nael Mostafa

Clin Pharmacol Ther· June 2025

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SERENE ER Analysis Part 1-SERENE CD: Exposure-Response Analysis of Higher Versus Standard Adalimumab Dosing Regimens for Patients With Moderately to Severely Active Crohn Disease.
Mong-Jen Chen, Ana Victoria Ponce-Bobadilla, Sven Stodtmann, Alexandra P Song, Tricia K Finney-Hayward, Nael M Mostafa

Clin Pharmacol Drug Dev· September 2024

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SERENE ER Analysis Part 2 SERENE-UC: Exposure-response Analysis of Higher Versus Standard Adalimumab Dosing Regimens for Patients with Moderately to Severely Active Ulcerative Colitis.
Sven Stodtmann, Mong-Jen Chen, Ana Victoria Ponce-Bobadilla, Tricia K Finney-Hayward, Jasmina Kalabic, Nael M Mostafa

Clin Pharmacol Drug Dev· September 2024

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Phase 1 study of safety and tolerability of an oral contraceptive containing low-dose ethinyl oestradiol combined with glecaprevir/pibrentasvir treatment in healthy premenopausal women.
Dee-Dee Shiller, Betty B Yao, Mong-Jen Chen, Amelia Orejudos, Nael M Mostafa

J Viral Hepat· July 2024

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Bioequivalence of Elagolix/Estradiol/Norethindrone Acetate Fixed-Dose Combination Product: Phase 1 Results in Healthy Pre- and Postmenopausal Women.
Mong-Jen Chen, Patrick Marroum, Yi-Lin Chiu, Melina Neenan, Nael M Mostafa

Clin Pharmacol Drug Dev· June 2024

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Therapeutic Development in Polyarticular Course Juvenile Idiopathic Arthritis: Extrapolation, Dose Selection, and Clinical Trial Design.
Laura E Schanberg, Lily Yeruk Mulugeta, Bolanle Akinlade, Hermine I Brunner, Jianmeng Chen, Nael M Mostafa

Arthritis Rheumatol· October 2023

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Assessment of Drug-Drug Interaction Risk Between Intravenous Fentanyl and the Glecaprevir/Pibrentasvir Combination Regimen in Hepatitis C Patients Using Physiologically Based Pharmacokinetic Modeling and Simulations.
Dwaipayan Mukherjee, Michelle Collins, Douglas E Dylla, Jatinder Kaur, Dimitri Semizarov, Nael M Mostafa

Infect Dis Ther· August 2023

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Assessing the Impact of Immunogenicity and Improving Prediction of Trough Concentrations: Population Pharmacokinetic Modeling of Adalimumab in Patients with Crohn's Disease and Ulcerative Colitis.
Ana Victoria Ponce-Bobadilla, Sven Stodtmann, Mong-Jen Chen, Insa Winzenborg, Sven Mensing, Nael M Mostafa

Clin Pharmacokinet· April 2023

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Interdisciplinary model-informed drug development for extending duration of elagolix treatment in patients with uterine fibroids.
Denise Beck, Insa Winzenborg, Wei Gao, Nael M Mostafa, Stephanie E Chiuve

Br J Clin Pharmacol· December 2022

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Bridging Fixed Dose to Body Weight-based Regimen of Adalimumab in Paediatric Ulcerative Colitis Using a Pharmacometric Modelling Approach: Case Study with the Phase 3 ENVISION I Trial.
Sven Stodtmann, Mong-Jen Chen, Lucia Siovitz, Mareike Bereswill, Andreas Lazar, Nael M Mostafa

J Crohns Colitis· November 2022

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Higher vs Standard Adalimumab Induction Dosing Regimens and Two Maintenance Strategies: Randomized SERENE CD Trial Results.
Geert R D'Haens, William J Sandborn, Edward V Loftus, Stephen B Hanauer, Stefan Schreiber, Nael M Mostafa

Gastroenterology· June 2022

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Higher vs Standard Adalimumab Induction and Maintenance Dosing Regimens for Treatment of Ulcerative Colitis: SERENE UC Trial Results.
Julián Panés, Jean-Frederic Colombel, Geert R D'Haens, Stefan Schreiber, Remo Panaccione, Nael M Mostafa

Gastroenterology· June 2022

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Effects of elagolix on the pharmacokinetics of omeprazole and its metabolites in healthy premenopausal women.
Ahmed Nader, Nael M Mostafa, Elaine Kim, Mohamad Shebley

Clin Transl Sci· May 2022

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Population Pharmacokinetics of Elagolix in Combination with Low-Dose Estradiol/Norethindrone Acetate in Women with Uterine Fibroids.
Denise Beck, Insa Winzenborg, Mohan Liu, Jacob Degner, Nael M Mostafa

Clin Pharmacokinet· April 2022

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Comparative Bioavailability of Two Formulations of Biopharmaceutical Classification System (BCS) Class IV Drugs: A Case Study of Lopinavir/Ritonavir.
Ahmed M Saeed, Jeffery M Schmidt, Wijith P Munasinghe, Bhadrish K Vallabh, Michael F Jarvis, Nael M Mostafa

J Pharm Sci· December 2021

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Efficacy and safety of adalimumab in paediatric patients with moderate-to-severe ulcerative colitis (ENVISION I): a randomised, controlled, phase 3 study.
Nicholas M Croft, William A Faubion, Subra Kugathasan, Jaroslaw Kierkus, Frank M Ruemmele, Nael M Mostafa

Lancet Gastroenterol Hepatol· August 2021

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Integrating real-world data and modeling to project changes in femoral neck bone mineral density and fracture risk in premenopausal women.
Denise Beck, Insa Winzenborg, Wei Gao, Nael M Mostafa, Peter Noertersheuser

Clin Transl Sci· July 2021

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Validation of a quantitative systems pharmacology model of calcium homeostasis using elagolix Phase 3 clinical trial data in women with endometriosis.
Sven Stodtmann, Ahmed Nader, Akshanth R Polepally, Ahmed A Suleiman, Insa Winzenborg, Nael M Mostafa

Clin Transl Sci· July 2021

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Drug-Drug Interaction Studies of Elagolix with Oral and Transdermal Low-Dose Hormonal Add-Back Therapy.
Ahmed Nader, Nael M Mostafa, Farah Ali, Mohamad Shebley

Clin Pharmacokinet· January 2021

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Assessment of Clinical Drug-Drug Interactions of Elagolix, a Gonadotropin-Releasing Hormone Receptor Antagonist.
Akshanth R Polepally, Juki W Ng, Ahmed Hamed Salem, Matthew B Dufek, Apurvasena Parikh, Nael M Mostafa

J Clin Pharmacol· December 2020

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Exposure-Safety Analyses Identify Predictors of Change in Bone Mineral Density and Support Elagolix Labeling for Endometriosis-Associated Pain.
Ahmed Abbas Suleiman, Ahmed Nader, Insa Winzenborg, Denise Beck, Akshanth R Polepally, Nael M Mostafa

CPT Pharmacometrics Syst Pharmacol· November 2020

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Effect of Elagolix Exposure on Clinical Efficacy End Points in Phase III Trials in Women With Endometriosis-Associated Pain: An Application of Markov Model.
Insa Winzenborg, Akshanth R Polepally, Ahmed Nader, Nael M Mostafa, Peter Noertersheuser

CPT Pharmacometrics Syst Pharmacol· August 2020

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A Genetic Variant in the BCL2 Gene Associates with Adalimumab Response in Hidradenitis Suppurativa Clinical Trials and Regulates Expression of BCL2.
Mohan Liu, Jacob Degner, Robert W Georgantas, Ahmed Nader, Nael M Mostafa

J Invest Dermatol· March 2020

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Clinical Pharmacology of Elagolix: An Oral Gonadotropin-Releasing Hormone Receptor Antagonist for Endometriosis.
Mohamad Shebley, Akshanth R Polepally, Ahmed Nader, Juki W Ng, Insa Winzenborg, Nael M Mostafa

Clin Pharmacokinet· March 2020

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