Publications by authors named "Timothy Nicholas"

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Impact of Model-Informed Drug Development on Drug Development Cycle Times and Clinical Trial Cost.
Vaishali Sahasrabudhe, Timothy Nicholas, Gianluca Nucci, Cynthia J Musante, Brian Corrigan

Clin Pharmacol Ther· August 2025

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Considering Opportunities and Challenges When Implementing the Model Master File Framework - a Meeting Report.
Eleftheria Tsakalozou, Lanyan Fang, Erin Skoda, Timothy Nicholas, Sivacharan Kollipara

Pharm Res· May 2025

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Industry Perspectives on Implementation of Model Master File (MMF) Framework for Generics and Innovator Drugs: Opportunities, Challenges and Future Outlook.
Sivacharan Kollipara, Markus Friden, Tycho Heimbach, Pratik Saha, Jan De Backer, Timothy Nicholas

Pharm Res· May 2025

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Peace in Health Care.
Timothy Nicholas, Grayson Holt

AMA J Ethics· November 2024

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Using Music to Teach Health Professions Students to Listen Closely and Promote Peace.
Timothy Nicholas, Lisa Rainsong, Erin Gentry Lamb

AMA J Ethics· November 2024

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Government Obligations and the Negative Right to a Healthy Urban Environment.
Sana Loue, Jared Ontko, Timothy Nicholas

AMA J Ethics· November 2024

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Automated Poisson regression exposure-response analysis for binary outcomes with PoissonERM.
Yuchen Wang, Luke Fostvedt, Jessica Wojciechowski, Donald Irby, Timothy Nicholas

CPT Pharmacometrics Syst Pharmacol· October 2024

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Meta-Analysis of Noncompartmental Pharmacokinetic Parameters to Evaluate the Impact of CYP2C19 and CYP2C9 Genetic Polymorphisms on Abrocitinib Exposure.
Luke Fostvedt, Jian Liu, Xiaoxing Wang, Yinhua Li, Jillian Johnson, Timothy Nicholas

Clin Pharmacol Drug Dev· October 2024

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Model-Informed Assessment of Probability of Phase 3 Success for Ritlecitinib in Patients with Moderate-to-Severe Ulcerative Colitis.
Jessica Wojciechowski, Arnab Mukherjee, Christopher Banfield, Timothy Nicholas

Clin Pharmacol Ther· September 2024

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Employing zero-inflated beta distribution in an exposure-response analysis of TYK2/JAK1 inhibitor brepocitinib in patients with plaque psoriasis.
Nikolaos Tsamandouras, Ruolun Qiu, Jim H Hughes, Kevin Sweeney, John P Prybylski, Timothy Nicholas

J Pharmacokinet Pharmacodyn· June 2024

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Realizing the promise of Project Optimus: Challenges and emerging opportunities for dose optimization in oncology drug development.
Wei Gao, Jiang Liu, Blerta Shtylla, Karthik Venkatakrishnan, Donghua Yin, Timothy Nicholas

CPT Pharmacometrics Syst Pharmacol· May 2024

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Tofacitinib pharmacokinetics in children and adolescents with juvenile idiopathic arthritis.
Cheng Chang, Camille Vong, Xiaoxing Wang, Anasuya Hazra, Annette Diehl, Timothy Nicholas

CPT Pharmacometrics Syst Pharmacol· April 2024

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Population pharmacokinetic modeling of oral brepocitinib in healthy volunteers and patients with immuno-inflammatory diseases.
Farzaneh Maleki, Elias Clark, Christopher Banfield, Wonkyung Byon, Timothy Nicholas

CPT Pharmacometrics Syst Pharmacol· April 2024

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Pharmacokinetic Profile of Brepocitinib with Topical Administration in Atopic Dermatitis and Psoriasis Populations: Strategy to Inform Clinical Trial Design in Adult and Pediatric Populations.
Farzaneh Maleki, Cheng Chang, Vivek S Purohit, Timothy Nicholas

Pharm Res· April 2024

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Dosing recommendation of nirmatrelvir/ritonavir using an integrated population pharmacokinetic analysis.
Phylinda L S Chan, Ravi Shankar P Singh, Donna S Cox, Haihong Shi, Bharat Damle, Timothy Nicholas

CPT Pharmacometrics Syst Pharmacol· December 2023

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Evolution of Ritlecitinib Population Pharmacokinetic Models During Clinical Drug Development.
Jessica Wojciechowski, Vivek S Purohit, Yeamin Huh, Christopher Banfield, Timothy Nicholas

Clin Pharmacokinet· December 2023

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The CARE (Curiosity, Attentiveness, Respect and Responsiveness, and Embodiment) Model: Operationalizing Cultural Humility in the Conduct of Clinical Research.
Sana Loue, Timothy Nicholas

Medicina (Kaunas)· November 2023

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Leveraging Prior Healthy Participant Pharmacokinetic Data to Evaluate the Impact of Renal and Hepatic Impairment on Ritlecitinib Pharmacokinetics.
Vivek Purohit, Yeamin Huh, Jessica Wojciechowski, Anna Plotka, Stephanie Salts, Timothy Nicholas

AAPS J· March 2023

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Population Pharmacokinetics of Oral Brepocitinib in Healthy Volunteers and Patients.
Jim H Hughes, Ruolun Qiu, Christopher Banfield, Martin E Dowty, Timothy Nicholas

Clin Pharmacol Drug Dev· December 2022

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Population PK and PD Analysis of Domagrozumab in Pediatric Patients with Duchenne Muscular Dystrophy.
Jessica Wojciechowski, Vivek S Purohit, Lutz O Harnisch, Pinky Dua, Beesan Tan, Timothy Nicholas

Clin Pharmacol Ther· December 2022

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Population Pharmacokinetic/Pharmacodynamic Modeling of the Effect of Abrocitinib on QT Intervals in Healthy Volunteers.
Xiaoxing Wang, Pankaj Gupta, Bimal K Malhotra, Saleem Ashley Farooqui, Vu H Le, Timothy Nicholas

Clin Pharmacol Drug Dev· September 2022

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Population pharmacokinetic-pharmacodynamic modelling of platelet time-courses following administration of abrocitinib.
Jessica Wojciechowski, Bimal K Malhotra, Xiaoxing Wang, Luke Fostvedt, Hernan Valdez, Timothy Nicholas

Br J Clin Pharmacol· August 2022

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Bridging Efficacy of Tofacitinib Immediate-Release to Extended-Release Formulations for Treatment of Ulcerative Colitis: Application of a Model-Informed Drug Development Approach.
Arnab Mukherjee, Shinichi Tsuchiwata, Cheng Chang, Timothy Nicholas, Chinyu Su

Clin Pharmacol Drug Dev· August 2022

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Exposure-Response Characterization of Tofacitinib Efficacy in Moderate to Severe Ulcerative Colitis: Results From Phase II and Phase III Induction and Maintenance Studies.
Arnab Mukherjee, Shinichi Tsuchiwata, Timothy Nicholas, Jack A Cook, Irene Modesto

Clin Pharmacol Ther· July 2022

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Correction to: Population Pharmacokinetics of Abrocitinib in Healthy Individuals and Patients with Psoriasis or Atopic Dermatitis.
Jessica Wojciechowski, Bimal K Malhotra, Xiaoxing Wang, Luke Fostvedt, Hernan Valdez, Timothy Nicholas

Clin Pharmacokinet· April 2022

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