Beach Reading

Authors: Zineh, Issam

Source: Pleiades: Literature in Context. 44(2):10-11

Availability: https://muse.jhu.edu/article/941228

The Baltimore Symphony Orchestra Performs Prokofiev's Romeo & Juliet

Authors: Zineh, Issam

Source: Pleiades: Literature in Context. 41(2):120-121

Availability: https://muse.jhu.edu/article/806257

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

Authors: Weber, Benjamin¹ (AUTHOR), Zineh, Issam² (AUTHOR), Lalonde, Richard³ (AUTHOR), Visser, Sandra A. G.⁴ (AUTHOR) sandra.a.g.visser@outlook.com

Source: CTS: Clinical & Translational Science. Jul2024, Vol. 17 Issue 7, p1-10. 10p.

Subject Terms: *CLINICAL decision support systems, *COGNITIVE bias, *RESEARCH bias, *RESEARCH & development, *JUDGMENT (Psychology)

A Multistakeholder Perspective on Advancing Individualized Therapeutics

Authors: Pacanowski, Michael, Vitarello, Julia, Hyun, Insoo, Yu, Timothy, Zineh, Issam

Source: Clinical pharmacology & therapeutics. 114(5):994-1001

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100195601950.0x000001&indx=1&recIds=ETOCvdc_100195601950.0x000001

US FDA Postmarketing Requirements and Commitments: A Systematic Assessment of Clinical Pharmacology Studies and Their Impact on US FDA Prescribing Information

Authors: Ridge, Sarah, Guinn, Daphne, Pfuma Fletcher, Elimika, Zineh, Issam, Madabushi, Rajanikanth, Ramamoorthy, Anuradha

Source: Journal of clinical pharmacology. 63(6):695-703

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100182477820.0x000001&indx=1&recIds=ETOCvdc_100182477820.0x000001

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

Authors: 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

Source: Clinical pharmacology & therapeutics. 113(1):71-79

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100181694112.0x000001&indx=1&recIds=ETOCvdc_100181694112.0x000001

Pharmacodynamic Biomarkers Evidentiary Considerations for Biosimilar Development and Approval

Authors: Strauss, David G., Wang, Yow‐Ming, Florian, Jeffry, Zineh, Issam

Source: Clinical pharmacology & therapeutics. 113(1):55-61

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100181693784.0x000001&indx=1&recIds=ETOCvdc_100181693784.0x000001

Model‐Based Approach to Selecting Pegfilgrastim Dose for Pharmacokinetic and Pharmacodynamic Similarity Studies in Biosimilar Development

Authors: Li, Fang, Sun, Qin, Du, Shengnan, Florian, Jeffry, Wang, Yaning, Huang, Shiew Mei, Zineh, Issam, Wang, Yow‐Ming C.

Source: Clinical pharmacology & therapeutics. 113(1):62-70

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100181693601.0x000001&indx=1&recIds=ETOCvdc_100181693601.0x000001

N. Oxford Avenue

Authors: ZINEH, ISSAM

Source: Agni, 2022 Jan 01(95), 34-35.

Access URL: https://www.jstor.org/stable/27301780

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

Authors: 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

Source: In eClinicalMedicine November 2021 41

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

Authors: 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

Source: CPT: pharmacometrics & systems pharmacology. 10(11):1271-1275

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100134769458.0x000001&indx=1&recIds=ETOCvdc_100134769458.0x000001

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

Authors: Yang, Xinning, Pfuma Fletcher, Elimika, Huang, Shiew‐Mei, Zineh, Issam, Madabushi, Rajanikanth

Source: Clinical pharmacology & therapeutics. 109(1):42-46

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100117431197.0x000001&indx=1&recIds=ETOCvdc_100117431197.0x000001

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

Authors: Guinn, Daphne, Madabushi, Rajanikanth, Wang, Yow‐Ming, Zineh, Issam, Maxfield, Kimberly

Source: Clinical pharmacology & therapeutics. 109(3):697-704

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100115864639.0x000001&indx=1&recIds=ETOCvdc_100115864639.0x000001

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

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

Source: Clinical pharmacology & therapeutics. 109(1):123-130

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100114609626.0x000001&indx=1&recIds=ETOCvdc_100114609626.0x000001

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

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

Source: Clinical pharmacology & therapeutics. 109(1):25-28

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100114609247.0x000001&indx=1&recIds=ETOCvdc_100114609247.0x000001

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

Authors: 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

Source: Clinical pharmacology & therapeutics. 110(2):285-288

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100123830215.0x000001&indx=1&recIds=ETOCvdc_100123830215.0x000001

Extrapolation of Adult Efficacy to Pediatric Patients With Chemotherapy‐Induced Nausea and Vomiting

Authors: Momper, Jeremiah D., Heinrichs, M. Tobias, Krudys, Kevin, Griebel, Donna, Kumar, Shaun, Kim, Insook, Mehrotra, Nitin, Mulberg, Andrew E., Garimella, Narayana, Nelson, Robert, Reaman, Gregory, Sinha, Vikram, Yao, Lynne, Zineh, Issam, Burckart, Gilbert, Sachs, Hari, Mulugeta, Yeruk

Source: Journal of clinical pharmacology. 60(6):775-784

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100107555615.0x000001&indx=1&recIds=ETOCvdc_100107555615.0x000001

Consideration of a Credibility Assessment Framework in Model‐Informed Drug Development: Potential Application to Physiologically‐Based Pharmacokinetic Modeling and Simulation

Authors: Kuemmel, Colleen, Yang, Yuching, Zhang, Xinyuan, Florian, Jeffry, Zhu, Hao, Tegenge, Million, Huang, Shiew‐Mei, Wang, Yaning, Morrison, Tina, Zineh, Issam

Source: CPT: pharmacometrics & systems pharmacology. 9(1):21-28

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100099814188.0x000001&indx=1&recIds=ETOCvdc_100099814188.0x000001

What's Past Is Prologue: Clinical Pharmacology at the Intersection of Science, Policy, and Patients

Authors: Zineh, Issam, Hartman, Dan

Source: Clinical pharmacology & therapeutics. 107(1):33-36

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100095987311.0x000001&indx=1&recIds=ETOCvdc_100095987311.0x000001

Communicating Immunogenicity-Associated Risk in Current U.S. FDA Prescription Drug Labeling: A Systematic Evaluation

Authors: Guinn, Daphne, Madabushi, Rajanikanth, Wang, Yow-Ming, Brodsky, Eric, Zineh, Issam, Maxfield, Kimberly

Source: Therapeutic innovation & regulatory science. 54(6):1363-1371

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100190765766.0x000001&indx=1&recIds=ETOCvdc_100190765766.0x000001