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

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Orthopedic Coordinated Registry Network (Ortho-CRN): advanced infrastructure for real-world evidence generation by Gressler, Laura Elisabeth, Devlin, Vincent, Jung, Mary, Marinac-Dabic, Danica, Sedrakyan, Art, Paxton, Elizabeth W, Franklin, Patricia, Navarro, Ronald, Ibrahim, Said, Forsberg, Jonathan, Voorhorst, Paul E, Zusterzeel, Robbert, Vitale, Michael, Marks, Michelle C, Newton, Peter O, Peat, Raquel

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Use of real-world data and clinical registries to identify new uses of existing vascular endografts: combined use of GORE EXCLUDER Iliac Branch Endoprosthesis and GORE VIABAHN VBX... by Barnes, Jonathan Aaron, Eid, Mark A, Moore, Kayla, Aryal, Suvekshya, Gebre, Eden, Woodard, Jennifer Nicole, Kitpanit, Napong, Mao, Jialin, Kuwayama, David P, Suckow, Bjoern D, Schneider, Darren, Abushaikha, Tiffany, Zusterzeel, Robbert, Vemulapalli, Sreekanth, Shenkman, Elizabeth A, Williams, James, Sedrakyan, Art, Goodney, Philip

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The Maastricht-Duke Bridge: an Era of Mentoring in Clinical Research – A Model for Mentoring in Clinical Research - A Tribute to Dr. Galen Wagner by Meijs, Loek, MD, Zusterzeel, Robbert, MD, PhD, Wellens, Hein JJ, MD, PhD, Gorgels, Anton PM, MD, PhD

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Left ventricular regional contraction abnormalities by echocardiographic speckle tracking in combined right bundle branch with left anterior fascicular block compared to left bundl... by Leeters, Irene P.M., BSc, Davis, Ashlee, RDCS, Zusterzeel, Robbert, MD, PhD, Atwater, Brett, MD, Risum, Niels, MD, PhD, Søgaard, Peter, MD, PhD, Klem, Igor, MD, Nijveldt, Robin, MD, PhD, Wagner, Galen S., MD, Gorgels, Anton P.M., MD, PhD, Kisslo, Joseph, MD

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Comparative Effectiveness of Cardiac Resynchronization Therapy Defibrillators Versus Standard Implantable Defibrillators in Medicare Patients by Zusterzeel, Robbert, MD, Caños, Daniel A., MPH, PhD, Sanders, William E., MD, MBA, Silverman, Henry, BS, MaCurdy, Thomas E., PhD, Worrall, Christopher M., BS, Kelman, Jeffrey, MD, MMSc, Marinac-Dabic, Danica, MD, PhD, Strauss, David G., MD, PhD

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Prevalence of manual Strauss LBBB criteria in patients diagnosed with the automated Glasgow LBBB criteria by Almer, Jakob, Zusterzeel, Robbert, MD, Strauss, David G., MD, PhD, Trägårdh, Elin, MD, PhD, Maynard, Charles, PhD, Wagner, Galen S., MD, Engblom, Henrik, MD, PhD

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Sex-Specific Mortality Risk by QRS Morphology and Duration in Patients Receiving CRT by Zusterzeel, Robbert, MD, Curtis, Jeptha P., MD, Caños, Daniel A., MPH, PhD, Sanders, William E., MD, MBA, Selzman, Kimberly A., MD, MPH, Piña, Ileana L., MD, MPH, Spatz, Erica S., MD, MHS, Bao, Haikun, PhD, Ponirakis, Angelo, PhD, Varosy, Paul D., MD, Masoudi, Frederick A., MD, MSPH, Strauss, David G., MD, PhD

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Effect of Sunscreen Application Under Maximal Use Conditions on Plasma Concentration of Sunscreen Active Ingredients: A Randomized Clinical Trial by Matta, Murali K, Zusterzeel, Robbert, Pilli, Nageswara R, Patel, Vikram, Volpe, Donna A, Florian, Jeffry, 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

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Sex Differences of Patients With Systemic Hypertension (From the Analysis of the Systolic Blood Pressure Intervention Trial [SPRINT]) by Ochoa-Jimenez, Roberto, Viquez-Beita, Karolina, Daluwatte, Chathuri, Zusterzeel, Robbert

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

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Influence of QRS infarct score and QRS duration prior to transcatheter aortic valve replacement on follow-up left ventricular end systolic volume in patients with new persistent le... by Hannink, Laura G.J., BSc, Wagner, Galen S., MD, Kisslo, Joseph, MD, Alenezi, Fawaz Abdulaziz M., MD, Shaw, Linda K., MS, Hofmann, Paul, BS, Zusterzeel, Robbert, MD, Phelan, Matthew, MS, Velazquez, Eric J., MD, Gorgels, Anton P.M., MD, PhD

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Assessment of Multi‐Ion Channel Block in a Phase I Randomized Study Design: Results of the CiPA Phase I ECG Biomarker Validation Study by Vicente, Jose, Zusterzeel, Robbert, Johannesen, Lars, Ochoa‐Jimenez, Roberto, Mason, Jay W., Sanabria, Carlos, Kemp, Sarah, Sager, Philip T., Patel, Vikram, Matta, Murali K., Liu, Jiang, Florian, Jeffry, Garnett, Christine, Stockbridge, Norman, Strauss, David G.

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Effectively Leveraging RWD for External Controls: A Systematic Literature Review of Regulatory and HTA Decisions by Sola‐Morales, Oriol, Curtis, Lesley H., Heidt, Julien, Walsh, Laura, Casso, Deborah, Oliveria, Susan, Saunders‐Hastings, Patrick, Song, Yufei, Mercado, Tiffany, Zusterzeel, Robbert, Mastey, Vera, Harnett, James, Quek, Ruben G. W.

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Effect of Oral Ranitidine on Urinary Excretion of N-Nitrosodimethylamine (NDMA): A Randomized Clinical Trial by Florian, Jeffry, Matta, Murali K, DePalma, Ryan, Gershuny, Victoria, Patel, Vikram, Hsiao, Cheng-Hui, Zusterzeel, Robbert, Rouse, Rodney, Prentice, Kristin, Nalepinski, Colleen Gosa, Kim, Insook, Yi, Sojeong, Zhao, Liang, Yoon, Miyoung, Selaya, Susan, Keire, David, Korvick, Joyce, Strauss, David G

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Novel simultaneous method for the determination of avobenzone and oxybenzone in human plasma by UHPLC-MS/MS with phospholipid removal pretreatment: An application to a sunscreen cl... by Pilli, Nageswara R., Narayanasamy, Suresh, Florian, Jeffry, Zusterzeel, Robbert, Patel, Vikram, Strauss, David G., Matta, Murali K.

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Regulatory and HTA Considerations for Development of Real‐World Data Derived External Controls by Curtis, Lesley H., Sola‐Morales, Oriol, Heidt, Julien, Saunders‐Hastings, Patrick, Walsh, Laura, Casso, Deborah, Oliveria, Susan, Mercado, Tiffany, Zusterzeel, Robbert, Sobel, Rachel E., Jalbert, Jessica J., Mastey, Vera, Harnett, James, Quek, Ruben G. W.

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Advancing Biosimilar Development Using Pharmacodynamic Biomarkers in Clinical Pharmacology Studies by Li, Junyi, Florian, Jeffry, Campbell, Elizabeth, Schrieber, Sarah J., Bai, Jane P.F., Weaver, James L., Hyland, Paula L., Thway, Theingi M., Matta, Murali K., Lankapalli, Rachana H., Narayanasamy, Suresh, Dancy, Jimena, Zusterzeel, Robbert, Tyson, Jessica Y., Prentice, Kristin W., Jackson, Kathryn C., Patel, Vikram, Rouse, Rodney L., Wang, Yow‐Ming C., Strauss, David G.

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Sex-Specific Mortality Risk by QRS Morphology and Duration in Patients Receiving CRT: Results From the NCDR by ZUSTERZEEL, Robbert, CURTIS, Jeptha P, MASOUDI, Frederick A, STRAUSS, David G, CANOS, Daniel A, SANDERS, William E, SELZMAN, Kimberly A, PINA, Ileana L, SPATZ, Erica S, HAIKUN BAO, PONIRAKIS, Angelo, VAROSY, Paul D

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Novel High-Throughput Quantitation of Potent hERG Blocker Dofetilide in Human Plasma by Liquid Chromatography Tandem Mass Spectrometry: Application in a Phase 1 ECG Biomarker Valid... by Matta, Murali K, Narayanasamy, Suresh, Vicente, Jose, Zusterzeel, Robbert, Patel, Vikram, Strauss, David G

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