Publications by authors named "Issam Zineh"

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Effect of Sunscreen Application on Plasma Concentration of Sunscreen Active Ingredients: A Randomized Clinical Trial.
Murali K Matta, Jeffry Florian, Robbert Zusterzeel, Nageswara R Pilli, Vikram Patel, Donna A Volpe, Yang Yang, Luke Oh, Edward Bashaw, Issam Zineh

JAMA· January 2020

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Effect of Sunscreen Application Under Maximal Use Conditions on Plasma Concentration of Sunscreen Active Ingredients: A Randomized Clinical Trial.
Murali K Matta, Robbert Zusterzeel, Nageswara R Pilli, Vikram Patel, Donna A Volpe, Jeffry Florian, Luke Oh, Edward Bashaw, Issam Zineh, Carlos Sanabria

JAMA· June 2019

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Landscape of FDA-Approved Targeted Therapies for the Treatment of Diseases with Low Frequency Molecular Subsets.
Lois S Akinola, Sarah Ridge, Issam Zineh, Michael A Pacanowski, Anuradha Ramamoorthy

J Clin Pharmacol· December 2025

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The US Food and Drug Administration's Model-Informed Drug Development Meeting Program: From Pilot to Pathway.
Rajanikanth Madabushi, Jessica Benjamin, Hao Zhu, Issam Zineh

Clin Pharmacol Ther· August 2024

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How debunking biases in research and development decisions could lead to more equitable healthcare?
Benjamin Weber, Issam Zineh, Richard Lalonde, Sandra A G Visser

Clin Transl Sci· July 2024

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Statin Drug-Drug Interactions: Pharmacokinetic Basis of FDA Labeling Recommendations and Comparison Across Common Tertiary Clinical Resources.
James Mease, Anuradha Ramamoorthy, Xinning Yang, Rajanikanth Madabushi, Elimika Pfuma Fletcher, Issam Zineh

J Clin Pharmacol· June 2024

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Using Machine Learning to Determine a Suitable Patient Population for Anakinra for the Treatment of COVID-19 Under the Emergency Use Authorization.
Qi Liu, Raj Nair, Ruihao Huang, Hao Zhu, Austin Anderson, Issam Zineh

Clin Pharmacol Ther· April 2024

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Clinical Pharmacology Approaches to Support Approval of New Routes of Administration for Therapeutic Proteins.
Yow-Ming C Wang, Ping Ji, Sudharshan Hariharan, Jie Wang, Olanrewaju Okusanya, Issam Zineh

Clin Pharmacol Ther· March 2024

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Intranasal Naloxone Repeat Dosing Strategies and Fentanyl Overdose: A Simulation-Based Randomized Clinical Trial.
David G Strauss, Zhihua Li, Anik Chaturbedi, Shilpa Chakravartula, Mohammadreza Samieegohar, Issam Zineh

JAMA Netw Open· January 2024

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A Multistakeholder Perspective on Advancing Individualized Therapeutics.
Michael Pacanowski, Julia Vitarello, Insoo Hyun, Timothy Yu, Issam Zineh

Clin Pharmacol Ther· November 2023

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US Food and Drug Administration embraces using innovation to identify optimized dosages for patients with cancer.
Stacy S Shord, Hao Zhu, Jiang Liu, Atiqur Rahman, Brian Booth, Issam Zineh

CPT Pharmacometrics Syst Pharmacol· November 2023

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US FDA Postmarketing Requirements and Commitments: A Systematic Assessment of Clinical Pharmacology Studies and Their Impact on US FDA Prescribing Information.
Sarah Ridge, Daphne Guinn, Elimika Pfuma Fletcher, Issam Zineh, Rajanikanth Madabushi

J Clin Pharmacol· June 2023

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Model-Based Approach to Selecting Pegfilgrastim Dose for Pharmacokinetic and Pharmacodynamic Similarity Studies in Biosimilar Development.
Fang Li, Qin Sun, Shengnan Du, Jeffry Florian, Yaning Wang, Issam Zineh

Clin Pharmacol Ther· January 2023

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Pharmacodynamic Biomarkers Evidentiary Considerations for Biosimilar Development and Approval.
David G Strauss, Yow-Ming Wang, Jeffry Florian, Issam Zineh

Clin Pharmacol Ther· January 2023

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Considerations for Use of Pharmacodynamic Biomarkers to Support Biosimilar Development - (I) A Randomized Trial with PCSK9 Inhibitors.
Morasa Sheikhy, Sarah J Schrieber, Qin Sun, Victoria Gershuny, Murali K Matta, Issam Zineh

Clin Pharmacol Ther· January 2023

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Concentration-Response Model of Immediate Release Oxycodone Drug Liking by Different Routes of Abuse.
Srikanth C Nallani, Wenjing Li, Silvia N Calderon, Ellen Fields, Rigoberto A Roca, Issam Zineh

Pain Med· July 2022

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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, Issam Zineh

CPT Pharmacometrics Syst Pharmacol· November 2021

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Association of partial systemic exposure and abuse potential for opioid analgesics with abuse deterrence labeling claims supporting product-specific guidance.
Liang Zhao, Zhichuan Li, Lanyan Fang, Myong-Jin Kim, Srikanth C Nallani, Issam Zineh

EClinicalMedicine· November 2021

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Evaluating Patients With Impaired Renal Function During Drug Development: Highlights From the 2019 US FDA Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting.
Martina D Sahre, Lauren Milligan, Rajanikanth Madabushi, Richard A Graham, Kellie S Reynolds, Issam Zineh

Clin Pharmacol Ther· August 2021

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Precision Dosing: A Clinical and Public Health Imperative.
Kimberly Maxfield, Issam Zineh

JAMA· April 2021

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Elucidating the Impact of Immunogenicity Assessment Postapproval: A Targeted Analysis of Immunogenicity Postmarketing Requirements and Commitments.
Daphne Guinn, Rajanikanth Madabushi, Yow-Ming Wang, Issam Zineh, Kimberly Maxfield

Clin Pharmacol Ther· March 2021

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Proceedings of a Workshop: Precision Dosing: Defining the Need and Approaches to Deliver Individualized Drug Dosing in the Real-World Setting.
Kimberly Maxfield, Lauren Milligan, Lingshan Wang, Daniel Gonzalez, Bernadette Johnson-Williams, Issam Zineh

Clin Pharmacol Ther· January 2021

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Regulatory Efforts to Facilitate Evaluation and Clinical Management of Drug-Drug Interaction Risks.
Xinning Yang, Elimika Pfuma Fletcher, Shiew-Mei Huang, Issam Zineh, Rajanikanth Madabushi

Clin Pharmacol Ther· January 2021

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A Systematic Assessment of US Food and Drug Administration Dosing Recommendations For Drug Development Programs Amenable to Response-Guided Titration.
Lingshan Wang, Kimberly Maxfield, Daphne Guinn, Rajanikanth Madabushi, Issam Zineh

Clin Pharmacol Ther· January 2021

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Communicating Immunogenicity-Associated Risk in Current U.S. FDA Prescription Drug Labeling: A Systematic Evaluation.
Daphne Guinn, Rajanikanth Madabushi, Yow-Ming Wang, Eric Brodsky, Issam Zineh

Ther Innov Regul Sci· November 2020

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Role of Guidance and Policy in Enhancing the Impact of Clinical Pharmacology in Drug Development, Regulation, and Use.
Rajanikanth Madabushi, Elimika Pfuma Fletcher, Jeffry Florian, Lauren Milligan, Anuradha Ramamoorthy, Issam Zineh

Clin Pharmacol Ther· October 2020

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Systematic Review of Device Parameters and Design of Studies Bridging Biologic-Device Combination Products Using Prefilled Syringes and Autoinjectors.
Ping Hu, Jie Wang, Jeffery Florian, Katherine Shatzer, Alan M Stevens, Issam Zineh

AAPS J· February 2020

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