Publications by authors named "Gerald Galluppi"

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Opportunities and Challenges of Hepatic Impairment Physiologically Based Pharmacokinetic Modeling in Drug Development-An IQ Perspective.
Hisham Qosa, Islam R Younis, Vaishali Sahasrabudhe, Ashish Sharma, Jin Yan, Gerald Galluppi

Clin Pharmacol Ther· June 2025

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Considerations for Industry-Preparing for the FDA Model-Informed Drug Development (MIDD) Paired Meeting Program.
Gerald R Galluppi, Malidi Ahamadi, Souvik Bhattacharya, Nageshwar Budha, Ferdous Gheyas

Clin Pharmacol Ther· August 2024

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Discovery and Model-Informed Drug Development of a Controlled-Release Formulation of Nonracemic Amisulpride that Reduces Plasma Exposure but Achieves Pharmacodynamic Bioequivalence in the Brain.
Seth C Hopkins, Siriporn Toongsuwan, Taryn J Corriveau, Takao Watanabe, Yuki Tsushima, Gerald R Galluppi

Clin Pharmacol Ther· August 2024

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Evaluation of OCT2-mediated drug-drug interactions between ulotaront and metformin in subjects with schizophrenia.
Guangqing Xiao, Hironobu Tsukada, Yu-Luan Chen, Lei Shi, Seth C Hopkins, Gerald R Galluppi

Pharmacol Res Perspect· April 2024

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A Phase I, Open-Label, Fixed Sequence Study to Investigate the Effect of Cytochrome P450 2D6 Inhibition on the Pharmacokinetics of Ulotaront in Healthy Subjects.
Hironobu Tsukada, Yu-Luan Chen, Guangqing Xiao, Lisa Lennek, Snezana M Milanovic, Gerald R Galluppi

Clin Pharmacokinet· December 2023

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Comparative Bioequivalence of Tablet and Capsule Formulations of Ulotaront and the Effect of Food on the Pharmacokinetics of the Tablet Form in Humans.
Yu-Luan Chen, Hironobu Tsukada, Snezana Milanovic, Lei Shi, Yan Li, Gerald R Galluppi

Neurol Ther· June 2023

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A randomized, single-dose, crossover study of the effects of ulotaront on electrocardiogram intervals in subjects with schizophrenia.
Hironobu Tsukada, Snezana M Milanovic, Borje Darpo, Hongqi Xue, Kuangnan Xiong, Gerald R Galluppi

Clin Transl Sci· June 2023

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ECG Evaluation as Part of the Clinical Pharmacology Strategy in the Development of New Drugs: A Review of Current Practices and Opportunities Based on Five Case Studies.
Borje Darpo, Marie Borin, Georg Ferber, Gerald R Galluppi, Seth C Hopkins

J Clin Pharmacol· December 2022

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In Vitro ADME and Preclinical Pharmacokinetics of Ulotaront, a TAAR1/5-HT Receptor Agonist for the Treatment of Schizophrenia.
Guangqing Xiao, Yu-Luan Chen, Nina Dedic, Linghong Xie, Kenneth S Koblan, Gerald R Galluppi

Pharm Res· May 2022

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A sensitive LC-MS/MS method for simultaneous quantification of ulotaront and its N-desmethyl metabolite in human plasma and application to a clinical study.
Yu-Luan Chen, Yao Shi, Amber LaFayette, Lei Shi, Kenneth S Koblan, Gerald R Galluppi

J Pharm Biomed Anal· January 2022

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Industrial Perspective on the Benefits Realized From the FDA's Model-Informed Drug Development Paired Meeting Pilot Program.
Gerald R Galluppi, Satjit Brar, Luzelena Caro, Yuan Chen, Nicolas Frey

Clin Pharmacol Ther· November 2021

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Population pharmacokinetic analysis of ulotaront in subjects with schizophrenia.
Gerald R Galluppi, Daniel G Polhamus, Jeannine M Fisher, Seth C Hopkins, Kenneth S Koblan

CPT Pharmacometrics Syst Pharmacol· October 2021

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Population pharmacokinetic analysis of apomorphine sublingual film or subcutaneous apomorphine in healthy subjects and patients with Parkinson's disease.
Felix Agbo, Ryan L Crass, Yu-Yuan Chiu, Sunny Chapel, Gerald Galluppi

Clin Transl Sci· July 2021

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The rate of dasotraline brain entry is slow following intravenous administration.
Robert Lew, Cristian C Constantinescu, Daniel Holden, Richard E Carson, Vincent Carroll, Gerald Galluppi

Psychopharmacology (Berl)· November 2020

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Evaluation of systemic absorption and bronchodilator effect of glycopyrronium bromide delivered by nebulizer or a dry powder inhaler in subjects with chronic obstructive pulmonary disease.
Brian R Leaker, Dave Singh, Grant C Nicholson, Blanka Hezelova, Thomas Goodin, Gerald Galluppi

Respir Res· June 2019

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Modeling and simulations to support dose selection for eslicarbazepine acetate therapy in pediatric patients with partial-onset seizures.
Soujanya Sunkaraneni, Elizabeth Ludwig, Jill Fiedler-Kelly, Seth Hopkins, Gerald Galluppi

J Pharmacokinet Pharmacodyn· August 2018

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Population pharmacokinetic and pharmacodynamic analysis of BIIB023, an anti-TNF-like weak inducer of apoptosis (anti-TWEAK) monoclonal antibody.
Gerald R Galluppi, Nicolas Wisniacki, Chris Stebbins

Br J Clin Pharmacol· July 2016

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Pharmacokinetics and pharmacodynamics of multiple doses of BG00010, a neurotrophic factor with anti-hyperalgesic effects, in patients with sciatica.
Pieter Okkerse, Justin L Hay, Eve Versage, Yongqiang Tang, Gerald Galluppi

Br J Clin Pharmacol· July 2016

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First-In-Human, Double-Blind, Placebo-Controlled, Randomized, Dose-Escalation Study of BG00010, a Glial Cell Line-Derived Neurotrophic Factor Family Member, in Subjects with Unilateral Sciatica.
Paul E Rolan, Gilmore O'Neill, Eve Versage, Jitesh Rana, Yongqiang Tang, Gerald Galluppi

PLoS One· February 2016

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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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A phase 1, open-label, dose-escalation study of BIIB022 (anti-IGF-1R monoclonal antibody) in subjects with relapsed or refractory solid tumors.
Margaret von Mehren, Carolyn D Britten, Peter Pieslor, Wayne Saville, Artemios Vassos, Gerald R Galluppi

Invest New Drugs· June 2014

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Phase I study of BIIB028, a selective heat shock protein 90 inhibitor, in patients with refractory metastatic or locally advanced solid tumors.
David Hong, Rabih Said, Gerald Falchook, Aung Naing, Stacy Moulder, Gerald Galluppi

Clin Cancer Res· September 2013

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Safety, tolerability, pharmacokinetics, and pharmacodynamics of anti-TWEAK monoclonal antibody in patients with rheumatoid arthritis.
Nicolas Wisniacki, Lakshmi Amaravadi, Gerald R Galluppi, Timothy S Zheng, Ray Zhang

Clin Ther· August 2013

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Acute lymphoid and gastrointestinal toxicity induced by selective p38alpha map kinase and map kinase-activated protein kinase-2 (MK2) inhibitors in the dog.
Dale L Morris, Shawn P O'Neil, Rajesh V Devraj, Joseph P Portanova, Richard W Gilles, Gerald R Galluppi

Toxicol Pathol· June 2010

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Plasma protein binding in drug discovery and development.
Monique L Howard, John J Hill, Gerald R Galluppi, Matthew A McLean

Comb Chem High Throughput Screen· February 2010

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