Quantitative Systems Pharmacology: A Regulatory Perspective on Translation

por Zineh, Issam
Publicado 2019

The clinical pharmacogeneticist: An emerging regulatory scientist at the US Food and Drug Administration

por Zineh, Issam, Woodcock, Janet
Publicado 2010

A Holistic and Integrative Approach for Advancing Model‐Informed Drug Development

por Madabushi, Rajanikanth, Wang, Yaning, Zineh, Issam
Publicado 2019

Pharmacogenetic Labeling of FDA-Approved Drugs: A Regulatory Retrospective

por Drozda, Katarzyna, Pacanowski, Michael A., Grimstein, Christian, Zineh, Issam
Publicado 2018

Pharmacodynamic Biomarkers Evidentiary Considerations for Biosimilar Development and Approval

por Strauss, David G., Wang, Yow‐Ming, Florian, Jeffry, Zineh, Issam
Publicado 2022

Serum Monocyte Chemoattractant Protein-1 Concentrations Associate With Diabetes Status but Not Arterial Stiffness in Children With Type 1 Diabetes

por Zineh, Issam, Beitelshees, Amber L., Silverstein, Janet H., Haller, Michael J.
Publicado 2009

Use of Titration as a Therapeutic Individualization Strategy: An Analysis of Food and Drug Administration–Approved Drugs

por Schuck, Robert N., Pacanowski, Michael, Kim, Sarah, Madabushi, Rajanikanth, Zineh, Issam
Publicado 2019

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

por Shord, Stacy S., Zhu, Hao, Liu, Jiang, Rahman, Atiqur, Booth, Brian, Zineh, Issam
Publicado 2023

CXCL5 polymorphisms are associated with variable blood pressure in cardiovascular disease-free adults

por Beitelshees, Amber L, Aquilante, Christina L, Allayee, Hooman, Langaee, Taimour Y, Welder, Gregory J, Schofield, Richard S, Zineh, Issam
Publicado 2012

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

por Kuemmel, Colleen, Yang, Yuching, Zhang, Xinyuan, Florian, Jeffry, Zhu, Hao, Tegenge, Million, Huang, Shiew‐Mei, Wang, Yaning, Morrison, Tina, Zineh, Issam
Publicado 2019

Epithelial Neutrophil-Activating Peptide (ENA-78), Acute Coronary Syndrome Prognosis, and Modulatory Effect of Statins

por Zineh, Issam, Beitelshees, Amber L., Welder, Gregory J., Hou, Wei, Chegini, Nasser, Wu, Jun, Cresci, Sharon, Province, Michael A., Spertus, John A.
Publicado 2008

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

por 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
Publicado 2021

Mechanistic Model‐Informed Proarrhythmic Risk Assessment of Drugs: Review of the “CiPA” Initiative and Design of a Prospective Clinical Validation Study

por Vicente, Jose, Zusterzeel, Robbert, Johannesen, Lars, Mason, Jay, Sager, Philip, Patel, Vikram, Matta, Murali K., Li, Zhihua, Liu, Jiang, Garnett, Christine, Stockbridge, Norman, Zineh, Issam, Strauss, David G.
Publicado 2017

Cardiovascular Pharmacogenomics: Current Status and Future Directions—Report of a National Heart, Lung, and Blood Institute Working Group

por Musunuru, Kiran, Roden, Dan M., Boineau, Robin, Bristow, Michael R., McCaffrey, Timothy A., Newton-Cheh, Christopher, Paltoo, Dina N., Rosenberg, Yves, Wohlgemuth, Jay G., Zineh, Issam, Hasan, Ahmed A. K.
Publicado 2012

Adrenergic gene polymorphisms and cardiovascular risk in the NHLBI-sponsored Women's Ischemia Syndrome Evaluation

por Pacanowski, Michael A, Zineh, Issam, Li, Haihong, Johnson, B Delia, Cooper-DeHoff, Rhonda M, Bittner, Vera, McNamara, Dennis M, Sharaf, Barry L, Merz, C Noel Bairey, Pepine, Carl J, Johnson, Julie A
Publicado 2008

Effects of genetic variation in H3K79 methylation regulatory genes on clinical blood pressure and blood pressure response to hydrochlorothiazide

por Duarte, Julio D, Zineh, Issam, Burkley, Ben, Gong, Yan, Langaee, Taimour Y, Turner, Stephen T, Chapman, Arlene B, Boerwinkle, Eric, Gums, John G, Cooper-DeHoff, Rhonda M, Beitelshees, Amber L, Bailey, Kent R, Fillingim, Roger B, Kone, Bruce C, Johnson, Julie A
Publicado 2012

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

por 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
Publicado 2021

Cancer Pharmacogenomics and Pharmacoepidemiology: Setting a Research Agenda to Accelerate Translation

por Freedman, Andrew N., Sansbury, Leah B., Figg, William D., Potosky, Arnold L., Weiss Smith, Sheila R., Khoury, Muin J., Nelson, Stefanie A., Weinshilboum, Richard M., Ratain, Mark J., McLeod, Howard L., Epstein, Robert S., Ginsburg, Geoffrey S., Schilsky, Richard L., Liu, Geoffrey, Flockhart, David A., Ulrich, Cornelia M., Davis, Robert L., Lesko, Lawrence J., Zineh, Issam, Randhawa, Gurvaneet, Ambrosone, Christine B., Relling, Mary V., Rothman, Nat, Xie, Heng, Spitz, Margaret R., Ballard-Barbash, Rachel, Doroshow, James H., Minasian, Lori M.
Publicado 2010