Safety and Immunogenicity of a Novel Staphylococcus aureus Vaccine: Results from the First Study of the Vaccine Dose Range in Humans von Harro, Clayton, Betts, Robert, Orenstein, Walter, Kwak, Eun-Jeong, Greenberg, Howard E, Onorato, Matthew T, Hartzel, Jon, Lipka, Joy, DiNubile, Mark J, Kartsonis, Nicholas

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Minimal Effects of Ritonavir and Efavirenz on the Pharmacokinetics of Raltegravir von IWAMOTO, Marian, WENNING, Larissa A, HAAZEN, Wouter, STONE, Julie A, GOTTESDIENER, Keith M, WAGNER, John A, PETRY, Amelia S, LAETHEM, Martine, DE SMET, Marina, KOST, James T, BREIDINGER, Sheila A, MANGIN, Eric C, AZROLAN, Neal, GREENBERG, Howard E

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Diurnal variation of the human adipose transcriptome and the link to metabolic disease von Loboda, Andrey, Kraft, Walter K, Fine, Bernard, Joseph, Jeffrey, Nebozhyn, Michael, Zhang, Chunsheng, He, Yudong, Yang, Xia, Wright, Christopher, Morris, Mark, Chalikonda, Ira, Ferguson, Mark, Emilsson, Valur, Leonardson, Amy, Lamb, John, Dai, Hongyue, Schadt, Eric, Greenberg, Howard E, Lum, Pek Yee

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Exposure-Dependent Inhibition of Intestinal and Hepatic CYP3A4 In Vivo by Grapefruit Juice von Veronese, Maria L., Gillen, Lisa P., Burke, Joanne P., Dorval, Ellen P., Hauck, Walter W., Pequignot, Ed, Waldman, Scott A., Greenberg, Howard E.

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Pharmacokinetics of Aprepitant After Single and Multiple Oral Doses in Healthy Volunteers von Majumdar, Anup K., Howard, Laura, Goldberg, Michael R., Hickey, Lisa, Constanzer, Marvin, Rothenberg, Paul L., Crumley, Tami M., Panebianco, Deborah, Bradstreet, Thomas E., Bergman, Arthur J., Waldman, Scott A., Greenberg, Howard E., Butler, Kathleen, Knops, A., De Lepeleire, Inge, Michiels, Nicole, Petty, Kevin J.

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American College of Clinical Pharmacology Position Statement on the Use of Microdosing in the Drug Development Process von Bertino Jr, Joseph S., Greenberg, Howard E., Reed, Michael D.

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The Pharmacokinetics of Taurolidine Metabolites in Healthy Volunteers von Gong, Li, Greenberg, Howard E., Perhach, James L., Waldman, Scott A., Kraft, Walter K.

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The Pharmacokinetics of Nebulized Nanocrystal Budesonide Suspension in Healthy Volunteers von Kraft, Walter K., Steiger, Barry, Beussink, Don, Quiring, John N., Fitzgerald, Nancy, Greenberg, Howard E., Waldman, Scott A.

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Effects of aprepitant on the pharmacokinetics of ondansetron and granisetron in healthy subjects von Blum, Robert A., Majumdar, Anup, McCrea, Jacqueline, Busillo, John, Orlowski, Laura H., Panebianco, Deborah, Hesney, Michael, Petty, Kevin J., Goldberg, Michael R., Murphy, M.Gail, Gottesdiener, Kevin M., Hustad, Carolyn M., Lates, Christian, Kraft, Walter K., Van Buren, Sandi, Waldman, Scott A., Greenberg, Howard E.

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Midazolam Single Time Point Concentrations to Estimate Exposure and Cytochrome P450 (CYP) 3A Constitutive Activity Utilizing Limited Sampling Strategy With a Population Pharmacokin... von Yang, Jincheng, Patel, Maulik, Nikanjam, Mina, Capparelli, Edmund V., Tsunoda, Shirley M., Greenberg, Howard E., Penzak, Scott R., Aubrey Stoch, S., Bertino, Joseph S., Nafziger, Anne N., Ma, Joseph D.

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Midazolam Limited Sampling Strategy With a Population Pharmacokinetic Approach to Simultaneously Estimate Cytochrome P450 (CYP) 3A Constitutive, Inhibition, and Induction/Activatio... von Yang, Jincheng, Nikanjam, Mina, Capparelli, Edmund V., Tsunoda, Shirley M., Greenberg, Howard E., Penzak, Scott R., Stoch, S. Aubrey, Bertino, Joseph S., Nafziger, Anne N., Ma, Joseph D.

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A call to incorporate systems theory and human factors into the existing investigation of harm in clinical research involving healthcare products von Edwards, Brian D., Bégaud, Bernard, Daemen, Esther, Dokas, Ioannis, Fishbein, Jonathan M., Greenberg, Howard E., Hochberg, Alan, Le Louet, Hervé, Lyngvig, Jytte, Mogles, Nataliya, Owen, Kathryn, Prendergast, Christine, Rejzek, Martin, Trantza, Sophia, Webb, David J., Whalen, Matthew, Whiteley, Simon

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MK-0448, a Specific Kv1.5 Inhibitor: Safety, Pharmacokinetics, and Pharmacodynamic Electrophysiology in Experimental Animal Models and Humans von Pavri, Behzad B, Greenberg, Howard E, Kraft, Walter K, Lazarus, Nicole, Lynch, Joseph J, Salata, Joseph J, Bilodeau, Mark T, Regan, Christopher P, Stump, Gary, Fan, Li, Mehta, Anish, Wagner, John A, Gutstein, David E, Bloomfield, Daniel

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Effects of Ezetimibe on Cyclosporine Pharmacokinetics in Healthy Subjects von Bergman, Arthur J., Burke, Joanne, Larson, Patrick, Johnson-Levonas, Amy O., Reyderman, Larisa, Statkevich, Paul, Kosoglou, Teddy, Greenberg, Howard E., Kraft, Walter K., Frick, Glenn, Murphy, Gail, Gottesdiener, Keith, Paolini, John F.

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Comprehensive review of visual defects reported with topiramate von Ford, Lisa, Goldberg, Jeffrey L, Selan, Fred, Greenberg, Howard E, Shi, Yingqi

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Is uveitis associated with topiramate use? A cumulative review von Goldberg, Jeffrey L, Lau, Amy G, Fan, Bo, Ford, Lisa, Greenberg, Howard E

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Structured Risk Assessment for First-in-Human Studies von van Iersel, Mattheus (Thijs), Greenberg, Howard E., Westrick, Mary L.

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Effect of Mibefradil on CYP3A4 In Vivo von Veronese, Maria L., Gillen, Lisa P., Dorval, Ellen P., Hauck, Walter W., Waldman, Scott A., Greenberg, Howard E.

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Hot Button Protocol and Operational Issues Between Sponsors and Sites in Clinical Pharmacology Studies: A Moderated Forum Session von Steinman, Gary L., Smith, William B., Westrick, Mary L., Greenberg, Howard E.

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Safety in FIH Trials: A Summary of the Symposium “Fatal Drug Trial in Phase 1: Understanding Risk, Subject Safety, Timelines, and Cost” von Greenberg, Howard E., van Iersel, Mattheus (Thijs), Westrick, Mary L., Smith, William B.

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