Publications by authors named "Joseph Grillo"

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First reported allergen immunotherapy anaphylaxis treated with neffy nasal spray: A case series.
Jake Rosenblum, Gregory Puglisi, Joseph Grillo

J Allergy Clin Immunol Glob· November 2025

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Coming full circle: The potential utility of real-world evidence to discern predictions from a physiologically based pharmacokinetic model.
Joseph A Grillo, Douglas McNair, Ping Zhao

Biopharm Drug Dispos· August 2023

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Development of best practices in physiologically based pharmacokinetic modeling to support clinical pharmacology regulatory decision-making-A workshop summary.
Daphney Jean, Kunal Naik, Lauren Milligan, Stephen Hall, Shiew Mei Huang, Joseph Grillo

CPT Pharmacometrics Syst Pharmacol· November 2021

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Application of PBPK Modeling and Simulation for Regulatory Decision Making and Its Impact on US Prescribing Information: An Update on the 2018-2019 Submissions to the US FDA's Office of Clinical Pharmacology.
Xinyuan Zhang, Yuching Yang, Manuela Grimstein, Jianghong Fan, Joseph A Grillo

J Clin Pharmacol· October 2020

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Translation of Drug Interaction Knowledge to Actionable Labeling.
Mongthuong T Tran, Joseph A Grillo

Clin Pharmacol Ther· June 2019

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Physiologically Based Pharmacokinetic Modeling in Regulatory Science: An Update From the U.S. Food and Drug Administration's Office of Clinical Pharmacology.
Manuela Grimstein, Yuching Yang, Xinyuan Zhang, Joseph Grillo, Shiew-Mei Huang

J Pharm Sci· January 2019

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Perspectives in regulatory science: translational and clinical pharmacology.
Joseph A Grillo, Shiew Mei Huang

Drug Discov Today Technol· February 2017

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The Application of Physiologically Based Pharmacokinetic Modeling to Predict the Role of Drug Transporters: Scientific and Regulatory Perspectives.
Yuzhuo Pan, Vicky Hsu, Manuela Grimstein, Lei Zhang, Vikram Arya, Joseph A Grillo

J Clin Pharmacol· July 2016

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Pharmacogenomic Biomarkers: an FDA Perspective on Utilization in Biological Product Labeling.
Robert N Schuck, Joseph A Grillo

AAPS J· May 2016

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Safety of graded challenge in allergic patients.
Megan K Ford, Joseph A Grillo, John R Cohn

J Allergy Clin Immunol Pract· December 2015

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Predicting the effect of cytochrome P450 inhibitors on substrate drugs: analysis of physiologically based pharmacokinetic modeling submissions to the US Food and Drug Administration.
Christian Wagner, Yuzhuo Pan, Vicky Hsu, Joseph A Grillo, Lei Zhang

Clin Pharmacokinet· January 2015

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U.S. Food and drug administration approval: obinutuzumab in combination with chlorambucil for the treatment of previously untreated chronic lymphocytic leukemia.
Hyon-Zu Lee, Barry W Miller, Virginia E Kwitkowski, Stacey Ricci, Pedro DelValle, Joseph Grillo

Clin Cancer Res· August 2014

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U.S. Food and Drug Administration approval summary: omacetaxine mepesuccinate as treatment for chronic myeloid leukemia.
Firoozeh Alvandi, Virginia E Kwitkowski, Chia-Wen Ko, Mark D Rothmann, Stacey Ricci, Joseph Grillo

Oncologist· January 2014

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U.S. Food and Drug Administration approval: ruxolitinib for the treatment of patients with intermediate and high-risk myelofibrosis.
Albert Deisseroth, Edvardas Kaminskas, Joseph Grillo, Wei Chen, Haleh Saber

Clin Cancer Res· June 2012

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Utility of a physiologically-based pharmacokinetic (PBPK) modeling approach to quantitatively predict a complex drug-drug-disease interaction scenario for rivaroxaban during the drug review process: implications for clinical practice.
Joseph A Grillo, Ping Zhao, Julie Bullock, Brian P Booth, Min Lu

Biopharm Drug Dispos· March 2012

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Evaluation of exposure change of nonrenally eliminated drugs in patients with chronic kidney disease using physiologically based pharmacokinetic modeling and simulation.
Ping Zhao, Manuela de L T Vieira, Joseph A Grillo, Pengfei Song, Ta-Chen Wu

J Clin Pharmacol· January 2012

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