Justin C. Earp

发表

Translational Quantitative Systems Pharmacology in Drug Development: from Current Landscape to Good Practices

Jane P. F. Bai, Justin C. Earp, Venkateswaran C. Pillai, 2019, The AAPS Journal.

Esomeprazole FDA Approval in Children With GERD: Exposure-Matching and Exposure-Response

Justin C. Earp, C. Garnett, J. van der Walt, 2017, Journal of pediatric gastroenterology and nutrition.

Whole Body PBPK Modeling of Remdesivir and Its Metabolites to Aid in Estimating Active Metabolite Exposure in the Lung and Liver in Patients With Organ Dysfunction

Justin C. Earp, Jianghong Fan, Xinyuan Zhang, 2021, Clinical pharmacology and therapeutics.

Modeling Corticosteroid Effects in a Rat Model of Rheumatoid Arthritis I: Mechanistic Disease Progression Model for the Time Course of Collagen-Induced Arthritis in Lewis Rats

Richard R. Almon, Debra C. DuBois, William J. Jusko, 2008, Journal of Pharmacology and Experimental Therapeutics.

U.S. Food and Drug Administration Approval: Ofatumumab for the Treatment of Patients with Chronic Lymphocytic Leukemia Refractory to Fludarabine and Alemtuzumab

Justin C. Earp, P. Keegan, R. Pazdur, 2010, Clinical Cancer Research.

Quantitative Dynamic Models of Arthritis Progression in the Rat

Richard R. Almon, Debra C. DuBois, William J. Jusko, 2008, Pharmaceutical Research.

Therapeutic Protein Drug–Drug Interactions: Navigating the Knowledge Gaps–Highlights from the 2012 AAPS NBC Roundtable and IQ Consortium/FDA Workshop

Justin C. Earp, R. Evers, Lei Zhang, 2013, The AAPS Journal.

Methods and strategies for assessing uncontrolled drug–drug interactions in population pharmacokinetic analyses: results from the International Society of Pharmacometrics (ISOP) Working Group

Justin C. Earp, P. Bonate, M. Karlsson, 2016, Journal of Pharmacokinetics and Pharmacodynamics.

A Simulation Approach to Evaluate the Impact of Patterns of Bioanalytical Bias Difference on the Outcome of Pharmacokinetic Similarity Studies

Justin C. Earp, T. Thway, Obinna N Obianom, 2020, Clinical pharmacology and therapeutics.

Role of Quantitative Clinical Pharmacology in Pediatric Approval and Labeling

Justin C. Earp, Jiang Liu, V. Sinha, 2016, Drug Metabolism and Disposition.

Dose-effect and concentration-effect analysis

Justin C. Earp, Yaning Wang, J. Lertora, 2022, Atkinson's Principles of Clinical Pharmacology.

Anti–SARS‐CoV‐2 Repurposing Drug Database: Clinical Pharmacology Considerations

Justin C. Earp, Jiang Liu, Shiew-Mei Huang, 2021, CPT: pharmacometrics & systems pharmacology.

Model‐Informed Drug Development Approaches to Assist New Drug Development in the COVID‐19 Pandemic

Justin C. Earp, Jiang Liu, Jianghong Fan, 2021, Clinical pharmacology and therapeutics.

Considerations and Challenges in the Remdesivir COVID‐19 Pediatric Development Program

Justin C. Earp, M. Sampson, K. Chan-Tack, 2022, Journal of clinical pharmacology.

Food and Drug Administration Approval : Ofatumumab the Treatment of Patients with Chronic Lymphocytic R kemia Refractory to Fludarabine and Alemtuzumab

Justin C. Earp, P. Keegan, R. Pazdur, 2010 .

Utility of population pharmacokinetic modeling in the assessment of therapeutic protein‐drug interactions

Justin C. Earp, A. Chow, Chuanpu Hu, 2014, Journal of clinical pharmacology.

FDA Approval Summary: Vemurafenib for Treatment of Unresectable or Metastatic Melanoma with the BRAFV600E Mutation

Justin C. Earp, Amy McKee, R. Pazdur, 2014, Clinical Cancer Research.

FDA approval summary: decitabine and cedazuridine tablets for myelodysplastic syndromes.

Justin C. Earp, R. Pazdur, M. Manning, 2022, Clinical cancer research : an official journal of the American Association for Cancer Research.

Role of Modeling and Simulation in the Development of Novel and Biosimilar Therapeutic Proteins.

S. J. Schrieber, Justin C. Earp, Yaning Wang, 2019, Journal of pharmaceutical sciences.

Pharmacokinetics of dexamethasone in a rat model of rheumatoid arthritis

Justin C. Earp, N. Pyszczynski, W. Jusko, 2008, Biopharmaceutics & drug disposition.

Impact of Pharmacometric Analyses on New Drug Approval and Labelling Decisions

Yaning Wang, Justin C. Earp, Christoffer Tornoe, 2011, Clinical pharmacokinetics.

Modeling effects of dexamethasone on disease progression of bone mineral density in collagen-induced arthritic rats

Justin C. Earp, D. DuBois, R. Almon, 2015, Pharmacology research & perspectives.

Model‐Informed Drug Development in Pediatric Dose Selection

Justin C. Earp, Jiang Liu, Xinyuan Zhang, 2021, Journal of clinical pharmacology.

Role of Model‐Informed Drug Development in Pediatric Drug Development, Regulatory Evaluation, and Labeling

Hao Zhu, Chao Liu, Yaning Wang, 2019, Journal of clinical pharmacology.

Synergism between Arsenic Trioxide and Heat Shock Protein 90 Inhibitors on Signal Transducer and Activator of Transcription Protein 3 Activity—Pharmacodynamic Drug-Drug Interaction Modeling

Justin C. Earp, W. Jusko, M. Brady, 2007, Clinical Cancer Research.

Translational Quantitative Systems Pharmacology in Drug Development: from Current Landscape to Good Practices

Justin C. Earp, J. Bai, V. Pillai, 2019, The AAPS Journal.

Methods and strategies for assessing uncontrolled drug–drug interactions in population pharmacokinetic analyses: results from the International Society of Pharmacometrics (ISOP) Working Group

Justin C. Earp, P. Bonate, M. Karlsson, 2016, Journal of Pharmacokinetics and Pharmacodynamics.

The Utility of a Population Approach in Drug–Drug Interaction Assessments: A Simulation Evaluation

Justin C. Earp, A. Chow, Chuanpu Hu, 2017, Journal of clinical pharmacology.

Assessment of Drug Interactions Relevant to Pharmacodynamic Indirect Response Models

Wojciech Krzyzanski, William J. Jusko, Justin C. Earp, 2004, Journal of Pharmacokinetics and Pharmacodynamics.

Modeling Corticosteroid Effects in a Rat Model of Rheumatoid Arthritis II: Mechanistic Pharmacodynamic Model for Dexamethasone Effects in Lewis Rats with Collagen-Induced Arthritis

Richard R Almon, William J Jusko, Justin C. Earp, 2008, Journal of Pharmacology and Experimental Therapeutics.

Down-regulation of heat shock protein 70 improves arsenic trioxide and 17-DMAG effects on constitutive signal transducer and activator of transcription 3 activity

Justin C. Earp, W. Jusko, M. Wetzler, 2010, Cancer Chemotherapy and Pharmacology.

Therapeutic Protein Drug–Drug Interactions: Navigating the Knowledge Gaps–Highlights from the 2012 AAPS NBC Roundtable and IQ Consortium/FDA Workshop

Justin C. Earp, R. Evers, Lei Zhang, 2013, The AAPS Journal.

Quantitative systems pharmacology: Landscape analysis of regulatory submissions to the US Food and Drug Administration

Justin C. Earp, D. Strauss, J. Bai, 2021, CPT: pharmacometrics & systems pharmacology.

FDA-Industry Scientific Exchange on assessing quantitative systems pharmacology models in clinical drug development: a meeting report, summary of challenges/gaps, and future perspective

Justin C. Earp, Christina M. Friedrich, K. Gadkar, 2021, The AAPS Journal.

A Perspective on Quantitative Systems Pharmacology Applications to Clinical Drug Development

David G Strauss, Justin C. Earp, Hao Zhu, 2020, CPT: pharmacometrics & systems pharmacology.

Synergism between ArsenicTrioxide and Heat Shock Protein 90 Inhibitors on SignalTransducer and Activator ofTranscription Protein 3 Activity!Pharmacodynamic Drug-Drug InteractionModeling

Justin C. Earp, M. Wetzler, M. Keng, 2007 .

Targeting 11q23 positive acute leukemia cells with high molecular weight-melanoma associated antigen-specific monoclonal antibodies

Justin C. Earp, S. Ferrone, S. Sait, 2009, Cancer Immunology, Immunotherapy.

Model‐Informed Approaches to Support Drug Development for Patients With Obesity: A Regulatory Perspective

Justin C. Earp, Y. Bi, Fang Li, 2023, Journal of clinical pharmacology.

Special Section on Pediatric Drug Disposition and Pharmacokinetics Role of Quantitative Clinical Pharmacology in Pediatric Approval and Labeling

Justin C. Earp, Jiang Liu, D. Tibboel, 2016 .