A framework to guide dose & regimen strategy for clinical drug development von Sander, Oliver, Magnusson, Baldur, Ludwig, Inga, Jullion, Astrid, Meille, Christophe, Lorand, Daniel, Bornkamp, Björn, Hinder, Markus, Kovacs, Steven J., Looby, Michael

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An Open-Label Study of the Impact of Hepatic Impairment on the Pharmacokinetics and Safety of Single Oral and Intravenous Doses of Omadacycline von Kovacs, Steven J, Ting, Lillian, Praestgaard, Jens, Sunkara, Gangadhar, Sun, Haiying, Stein, Daniel S, Tanaka, S Ken, Villano, Stephen

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Randomized, Open-Label Study of the Pharmacokinetics and Safety of Oral and Intravenous Administration of Omadacycline to Healthy Subjects von Sun, Haiying, Ting, Lillian, Machineni, Surendra, Praestgaard, Jens, Kuemmell, Andreas, Stein, Daniel S, Sunkara, Gangadhar, Kovacs, Steven J, Villano, Stephen, Tanaka, S Ken

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Correction for Kovacs et al., "An Open-Label Study of the Impact of Hepatic Impairment on the Pharmacokinetics and Safety of Single Oral and Intravenous Doses of Omadacycline" von Kovacs, Steven J, Ting, Lillian, Praestgaard, Jens, Sunkara, Gangadhar, Sun, Haiying, Stein, Daniel S, Tanaka, S Ken, Villano, Stephen

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Nonclinical and clinical characterization of MAU868, a novel human-derived monoclonal neutralizing antibody targeting BK polyomavirus VP1 von Abend, Johanna R., Sathe, Atul, Wrobel, Matthias B., Knapp, Mark, Xu, Lucy, Zhao, Lihong, Kim, Peter, Desai, Sachin, Nguyen, Amanda, Leber, Xavier-Charles, Hein, Andreas, Scharenberg, Meike, Shaul, Jacob, Ornelas, Elisabeth, Wong, Kelly, Pietzonka, Thomas, Sterling, Laura M., Hodges, Michael R., Pertel, Peter, Traggiai, Elisabetta, Patick, Amy K., Kovacs, Steven J.

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Challenges and Opportunities in the Development of Medical Therapies for Pediatric Populations and the Role of Extrapolation von Barrett, Jeffrey S., Bishai, Raafat, Bucci‐Rechtweg, Christina, Cheung, Amy, Corriol‐Rohou, Solange, Haertter, Sebastian, James, Angela, Kovacs, Steven J., Liu, Jing, Potempa, Dennis, Strougo, Ashley, Vanevski, Konstantina

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The effects of CYP3A4 induction and inhibition on the pharmacokinetics of alisporivir in humans von Barve, Avantika, Kovacs, Steven J., Ke, June, Crabbe, Rafael, Grosgurin, Peter, Menetrey, Annick, Nicolas-Métral, Valerie, Dabovic, Kristina, Dole, Kiran, Zhang, Jie, Praestgaard, Jens, Sunkara, Gangadhar, Stein, Daniel

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The Safety and Antiviral Activity of BZF961 with or without Ritonavir in Patients Infected with Hepatitis C Virus: A Randomized, Multicenter Trial von Lawitz, Eric, Bidair, Mohamed, Marbury, Thomas, Jones, Christopher T., Barve, Avantika, Magnusson, Baldur, Barkan, David T., Bodendorf, Ursula, Bracken, Kathryn, Canino, Erica, Chen, Darlene, Dabovic, Kristina, Heimbach, Tycho, Ison, Marjorie, Jones, Catherine L., Kovacs, Steven J., Lakshman, Jay P., Li, Bin, Raman, Prakash, Steiner-Swiat, Rachael, Thohan, Sanjeev, Wong, Kelly A., Zhong, Weidong, Colvin, Richard A.

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Sa1081 Therapeutic Dose Effects of the Cyclophilin Inhibitor Alisporivir (ALV) on Circulating Bilirubin Concentrations in Healthy Subjects von Kovacs, Steven J, Ke, June, Dabovic, Kristina, Barve, Avantika, Stein, Daniel

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Sa1031 Mild to Moderate Hepatic Impairment Has No Effect on the Single Dose Pharmacokinetics of Alisporivir (ALV) von Kovacs, Steven J, Ke, June, Praestgaard, Jens, Barve, Avantika, Zhang, Jie, Maietta, Robert, Sunkara, Gangadhar, Stein, Daniel S

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Future Clinical Pharmacy Practitioners Should Be Board-Certified Specialists von Saseen, Joseph J., Grady, Sarah E., Hansen, Laura B., Hodges, Brian M., Kovacs, Steven J., Martinez, Larry D., Murphy, John E., Page II, Robert L., Reichert, Marc G., Stringer, Kathleen A., Taylor, Charles T.

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A First-in-Human Study of MAU868, a Novel Neutralizing Antibody Against BK Virus: PO2455 von Kovacs, Steven J., Abend, Johanna R., Xu, Xiaoying, Desai, Sachin, Nguyen, Amanda, Sterling, Laura M., Hodges, Michael R., Pertel, Peter

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The Bioequivalence of Telithromycin Administered Orally as Crushed Tablets Versus Tablets Swallowed Whole von Lippert, Christina, Gbenado, Seth, Qiu, Chunfu, Lavin, Bruce, Kovacs, Steven J.

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Morning Spot and 24-Hour Urinary 6β-Hydroxycortisol to Cortisol Ratios: Intraindividual Variability and Correlation under Basal Conditions and Conditions of CYP 3A4 Induction von Tran, Jonathan Q., Kovacs, Steven J., McIntosh, Thomas S., Davis, Hugh M., Martin, David E.

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Preclinical Characterization of MAU868, a Novel Neutralizing Antibody Targeting BK Virus: PO2367 von Sathe, Atul, Knapp, Mark, Zhao, Lihong, Kim, Peter, Hein, Andreas, Scharenberg, Meike, Shaul, Jacob, Wong, Kelly A., Kovacs, Steven J., Traggiai, Elisabetta, Patick, Amy, Abend, Johanna R.

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An Individual Perspective on the Pharmacy Education Scope of Practice Disconnect von Kovacs, Steven J.

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Population pharmacokinetics of the active metabolite of leflunomide in pediatric subjects with polyarticular course juvenile rheumatoid arthritis von JUN SHI, KOVACS, Steven J, YANING WANG, LUDDEN, Thomas M, BHARGAVA, Vijay O

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Urinary excretion of 6β-hydroxycortisol as an in vivo marker for CYP3A induction: Applications and recommendations von Kovacs, Steven J., Martin, David E., Everitt, Daniel E., Patterson, Scott D., Jorkasky, Diane K.

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DOSING OF POLYOMAVIRUS NEUTRALIZING ANTIBODIES von ABEND, Johanna, R, KOVACS, Steven, J, TRAGGIAI, Elisabetta, PATICK, Amy, K, KNAPP, Mark

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DOSING OF POLYOMAVIRUS NEUTRALIZING ANTIBODIES von KOVACS, Steven J, TRAGGIAI, Elisabetta, ABEND, Johanna R, KNAPP, Mark, PATICK, Amy K

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