Issam Zineh - Publications, H-index & Citations

Issam Zineh

State University System of Florida

40H指数

255论文数

7.2K被引数

收录论文 83

发表时间

How debunking biases in research and development decisions could lead to more equitable healthcare?

CTS-CLINICAL AND TRANSLATIONAL SCIENCE

IF2.8

2024-07-17

OAAI

Weber, Benjamin; Zineh, Issam; Lalonde, Richard; Visser, Sandra A. G.

The US Food and Drug Administration's Model-Informed Drug Development Meeting Program: From Pilot to Pathway

CLINICAL PHARMACOLOGY & THERAPEUTICS

IF5.5

2024-03-06

PREAI

Madabushi, Rajanikanth; Benjamin, Jessica; Zhu, Hao; Zineh, Issam

Using Machine Learning to Determine a Suitable Patient Population for Anakinra for the Treatment of COVID-19 Under the Emergency Use Authorization

CLINICAL PHARMACOLOGY & THERAPEUTICS

IF5.5

2024-02-13

OAAI

Liu, Qi; Nair, Raj; Huang, Ruihao; Zhu, Hao; Anderson, Austin; Belen, Ozlem; Tran, Van; Chiu, Rebecca; Higgins, Karen; Chen, Jianmeng; He, Lei; Doddapaneni, Suresh; Huang, Shiew-Mei; Nikolov, Nikolay P.; Zineh, Issam

Intranasal Naloxone Repeat Dosing Strategies and Fentanyl Overdose A Simulation-Based Randomized Clinical Trial

JAMA NETWORK OPEN

IF9.7

2024-01-23

OAAI

Strauss, David G.; Li, Zhihua; Chaturbedi, Anik; Chakravartula, Shilpa; Samieegohar, Mohammadreza; Mann, John; Nallani, Srikanth C.; Prentice, Kristin; Shah, Aanchal; Burkhart, Keith; Boston, Jennifer; Fu, Yu-Hui Ann; Dahan, Albert; Zineh, Issam; Florian, Jeffry A.

Clinical Pharmacology Approaches to Support Approval of New Routes of Administration for Therapeutic Proteins

CLINICAL PHARMACOLOGY & THERAPEUTICS

IF5.5

2024-01-18

PREAI

Wang, Yow-Ming C.; Ji, Ping; Hariharan, Sudarshan; Wang, Jie; Okusanya, Olanrewaju; Abuasal, Bilal; Zhu, Hao; Madabushi, Rajanikanth; Huang, Shiew Mei; Zineh, Issam

A Multistakeholder Perspective on Advancing Individualized Therapeutics

CLINICAL PHARMACOLOGY & THERAPEUTICS

IF5.5

2023-09-13

OAAI

Pacanowski, Michael; Vitarello, Julia; Hyun, Insoo; Yu, Timothy; Zineh, Issam

US Food and Drug Administration embraces using innovation to identify optimized dosages for patients with cancer

CPT-PHARMACOMETRICS & SYSTEMS PHARMACOLOGY

IF3

2023-08-28

OAAI

Shord, Stacy S.; Zhu, Hao; Liu, Jiang; Rahman, Atiqur; Booth, Brian; Zineh, Issam

Considerations for Use of Pharmacodynamic Biomarkers to Support Biosimilar Development - (I) A Randomized Trial with PCSK9 Inhibitors

CLINICAL PHARMACOLOGY & THERAPEUTICS

IF5.5

2022-11-15

PREAI

Sheikhy, Morasa; Schrieber, Sarah J.; Sun, Qin; Gershuny, Victoria; Matta, Murali K.; Bai, Jane P. F.; Du, Xiulian; Vegesna, Giri; Shah, Aanchal; Prentice, Kristin; Nalepinski, Colleen; Zineh, Issam; Wang, Yow-Ming; Strauss, David G.; Florian, Jeffry

Pharmacodynamic Biomarkers Evidentiary Considerations for Biosimilar Development and Approval

CLINICAL PHARMACOLOGY & THERAPEUTICS

IF5.5

2022-11-02

OAAI

Strauss, David G.; Wang, Yow-Ming; Florian, Jeffry; Zineh, Issam

Association of partial systemic exposure and abuse potential for opioid analgesics with abuse deterrence labeling claims supporting product-specific guidance

ECLINICALMEDICINE

IF10

2021-11-01

OAAI

Zhao, Liang; Li, Zhichuan; Fang, Lanyan; Kim, Myong-Jin; Nallani, Srikanth C.; Sahajwalla, Chandrahas G.; Calderon, Silvia N.; Roca, Rigoberto A.; Feng, Kairui; Zineh, Issam; Lionberger, Robert

Development of best practices in physiologically based pharmacokinetic modeling to support clinical pharmacology regulatory decision-making-A workshop summary

CPT-PHARMACOMETRICS & SYSTEMS PHARMACOLOGY

IF3

2021-09-18

OAAI

Jean, Daphney; Naik, Kunal; Milligan, Lauren; Hall, Stephen; Mei Huang, Shiew; Isoherranen, Nina; Kuemmel, Colleen; Seo, Paul; Tegenge, Million A.; Wang, Yaning; Yang, Yuching; Zhang, Xinyuan; Zhao, Liang; Zhao, Ping; Benjamin, Jessica; Bergman, Kimberly; Grillo, Joseph; Madabushi, Rajanikanth; Wu, Fang; Zhu, Hao; Zineh, Issam

Evaluating Patients With Impaired Renal Function During Drug Development: Highlights From the 2019 US FDA Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting

CLINICAL PHARMACOLOGY & THERAPEUTICS

IF5.5

2021-02-16

PREAI

Sahre, Martina D.; Milligan, Lauren; Madabushi, Rajanikanth; Graham, Richard A.; Reynolds, Kellie S.; Terzic, Andre; Benjamin, Jessica; Burckart, Gilbert J.; Huang, Shiew-Mei; Schuck, Robert; Thompson, Aliza M.; Zineh, Issam

A Systematic Assessment of US Food and Drug Administration Dosing Recommendations For Drug Development Programs Amenable to Response-Guided Titration

CLINICAL PHARMACOLOGY & THERAPEUTICS

IF5.5

2020-11-15

OAAI

Wang, Lingshan; Maxfield, Kimberly; Guinn, Daphne; Madabushi, Rajanikanth; Zineh, Issam; Schuck, Robert N.

Elucidating the Impact of Immunogenicity Assessment Postapproval: A Targeted Analysis of Immunogenicity Postmarketing Requirements and Commitments

CLINICAL PHARMACOLOGY & THERAPEUTICS

IF5.5

2020-09-28

PREAI

Guinn, Daphne; Madabushi, Rajanikanth; Wang, Yow-Ming; Zineh, Issam; Maxfield, Kimberly

Regulatory Efforts to Facilitate Evaluation and Clinical Management of Drug-Drug Interaction Risks

CLINICAL PHARMACOLOGY & THERAPEUTICS

IF5.5

2020-07-28

PREAI

Yang, Xinning; Pfuma Fletcher, Elimika; Huang, Shiew-Mei; Zineh, Issam; Madabushi, Rajanikanth

Proceedings of a Workshop: Precision Dosing: Defining the Need and Approaches to Deliver Individualized Drug Dosing in the Real-World Setting

CLINICAL PHARMACOLOGY & THERAPEUTICS

IF5.5

2020-07-14

OAAI

Maxfield, Kimberly; Milligan, Lauren; Wang, Lingshan; Gonzalez, Daniel; Johnson-Williams, Bernadette; Liu, Qi; Madabushi, Rajanikanth; Powell, Robert; Wang, Yaning; Zhu, Hao; Zineh, Issam

Role of Guidance and Policy in Enhancing the Impact of Clinical Pharmacology in Drug Development, Regulation, and Use

CLINICAL PHARMACOLOGY & THERAPEUTICS

IF5.5

2020-05-19

OAAI

Madabushi, Rajanikanth; Fletcher, Elimika Pfuma; Florian, Jeffry; Milligan, Lauren; Ramamoorthy, Anuradha; Yang, Xinning; Maxfield, Kimberly; Sahre, Martina; Jean, Daphney; Zhang, Lei; Green, Dionna; Zineh, Issam

Systematic Review of Device Parameters and Design of Studies Bridging Biologic-Device Combination Products Using Prefilled Syringes and Autoinjectors

AAPS JOURNAL

IF3.7

2020-02-27

PREAI

Hu, Ping; Wang, Jie; Florian, Jeffery; Shatzer, Katherine; Stevens, Alan M.; Gertz, Jacqueline; Ji, Ping; Huang, Shiew Mei; Zineh, Issam; Wang, Yow-Ming C.

Scientific and Regulatory Considerations for an Ontogeny Knowledge Base for Pediatric Clinical Pharmacology

CLINICAL PHARMACOLOGY & THERAPEUTICS

IF5.5

2020-01-26

OAAI

Burckart, Gilbert J.; Seo, Shirley; Pawlyk, Aaron C.; McCune, Susan K.; Yao, Lynne P.; Giacoia, George P.; Wang, Yaning; Zineh, Issam

Effect of Sunscreen Application on Plasma Concentration of Sunscreen Active Ingredients A Randomized Clinical Trial

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

IF55

2020-01-21

175

OAAI

Matta, Murali K.; Florian, Jeffry; Zusterzeel, Robbert; Pilli, Nageswara R.; Patel, Vikram; Volpe, Donna A.; Yang, Yang; Oh, Luke; Bashaw, Edward; Zineh, Issam; Sanabria, Carlos; Kemp, Sarah; Godfrey, Anthony; Adah, Steven; Coelho, Sergio; Wang, Jian; Furlong, Lesley-Anne; Ganley, Charles; Michele, Theresa; Strauss, David G.

研究方向