Search Results - "HAERTTER, Sebastian"

Dabigatran etexilate--a novel, reversible, oral direct thrombin inhibitor: interpretation of coagulation assays and reversal of anticoagulant activity by van Ryn, Joanne, Stangier, Joachim, Haertter, Sebastian, Liesenfeld, Karl-Heinz, Wienen, Wolfgang, Feuring, Martin, Clemens, Andreas

“…Dabigatran etexilate is an oral, reversible direct thrombin inhibitor that is approved in the EU and several other countries for the prevention of venous…”
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Pharmacokinetics of a Once-Daily extended-release formulation of pramipexole in healthy male volunteers: Three studies by Jenner, Peter, PhD, DSc, Könen-Bergmann, Michael, MD, Schepers, Cornelia, MSc, Haertter, Sebastian, PhD

“…Abstract Background: Pramipexole is a dopamine agonist used in the treatment of Parkinson's disease. The currently available immediate-release (IR) formulation…”
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To blind or not to blind first in human and exploratory clinical trials: Acceleration of development vs. risk of bias by Haertter, Sebastian, Kanodia, Jitendar, Cook, Jack, Alicea, Jeanette, Brennan, Bonnie J., Desai, Amit, Patel, Bela, Pan, Lin, Goteti, Kosalaram

“…An IQ consortium working group (WG) conducted a survey across multiple biopharmaceutical companies to gain information about the level of blinding commonly…”
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The Effect of Dabigatran Plasma Concentrations and Patient Characteristics on the Frequency of Ischemic Stroke and Major Bleeding in Atrial Fibrillation Patients by Reilly, Paul A., PhD, Lehr, Thorsten, PhD, Haertter, Sebastian, PhD, Connolly, Stuart J., MD, Yusuf, Salim, MD, DPhil, Eikelboom, John W., MB BS, Ezekowitz, Michael D., MD, PhD, Nehmiz, Gerhard, PhD, Wang, Susan, PhD, Wallentin, Lars, MD, PhD

“…Objectives The goal of this study was to analyze the impact of dabigatran plasma concentrations, patient demographics, and aspirin (ASA) use on frequencies of…”
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Oral bioavailability of dabigatran etexilate (Pradaxa®) after co‐medication with verapamil in healthy subjects by Härtter, Sebastian, Sennewald, Regina, Nehmiz, Gerhard, Reilly, Paul

“…Aim To investigate the effect of the P‐glycoprotein inhibitor verapamil on the pharmacokinetics and pharmacodynamics of dabigatran etexilate (DE). Method In…”
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Clinical pharmacokinetics and pharmacodynamics of empagliflozin in patients with heart failure by Rascher, Juliane, Cotton, Dan, Haertter, Sebastian, Brueckmann, Martina

“…Aims The aim of this work is to compare empagliflozin systemic exposure between patients with heart failure (HF) and patients with type 2 diabetes (T2D)…”
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The Effect of Dabigatran Plasma Concentrations and Patient Characteristics on the Frequency of Ischemic Stroke and Major Bleeding in Atrial Fibrillation Patients: The RE-LY Trial (Randomized Evaluation of Long-Term Anticoagulation Therapy) by REILLY, Paul A, LEHR, Thorsten, HAERTTER, Sebastian, CONNOLLY, Stuart J, YUSUF, Salim, EIKELBOOM, John W, EZEKOWITZ, Michael D, NEHMIZ, Gerhard, SUSAN WANG, WALLENTIN, Lars

“…The goal of this study was to analyze the impact of dabigatran plasma concentrations, patient demographics, and aspirin (ASA) use on frequencies of ischemic…”
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Association between statin use and ischemic stroke or major hemorrhage in patients taking dabigatran for atrial fibrillation by Haertter, Sebastian, Huang, Fenglei, Franca, Lionel Riou

“…It is unclear whether, for their comparisons, the authors focused on patients initiating treatment and assessed baseline characteristics at that time point…”
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Effective elimination of dabigatran by haemodialysis. A phase I single-centre study in patients with end-stage renal disease by Khadzhynov, Dmytro, Wagner, Frank, Formella, Stephan, Wiegert, Erol, Moschetti, Viktoria, Slowinski, Torsten, Neumayer, Hans-H, Liesenfeld, Karl-Heinz, Lehr, Thorsten, Härtter, Sebastian, Friedman, Jeffrey, Peters, Harm, Clemens, Andreas

“…Dabigatran, a specific, reversible direct thrombin inhibitor, is used to prevent ischaemic and haemorrhagic strokes in patients with atrial fibrillation. As…”
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Genetic Determinants of Dabigatran Plasma Levels and Their Relation to Bleeding by PARE, Guillaume, ERIKSSON, Niclas, SIEGBAHN, Agneta, SYVANEN, Ann-Christine, WADELIUS, Claes, WADELIUS, Mia, ZIMDAHL-GELLING, Heike, YUSUF, Salim, WALLENTIN, Lars, LEHR, Thorsten, CONNOLLY, Stuart, EIKELBOOM, John, EZEKOWITZ, Michael D, AXELSSON, Tomas, HAERTTER, Sebastian, OLDGREN, Jonas, REILLY, Paul

“…Fixed-dose unmonitored treatment with dabigatran etexilate is effective and has a favorable safety profile in the prevention of stroke in atrial fibrillation…”
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Decrease in the oral bioavailability of dabigatran etexilate after co‐medication with rifampicin by Härtter, Sebastian, Koenen‐Bergmann, Michael, Sharma, Ashish, Nehmiz, Gerhard, Lemke, Ute, Timmer, Wolfgang, Reilly, Paul A.

“…WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT • Dabigatran etexilate is an oral prodrug that is rapidly converted to dabigatran, a direct and reversible thrombin…”
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Roadmap to 2030 for Drug Evaluation in Older Adults by Liu, Qi, Schwartz, Janice B., Slattum, Patricia W., Lau, S.W. Johnny, Guinn, Daphne, Madabushi, Rajanikanth, Burckart, Gilbert, Califf, Robert, Cerreta, Francesca, Cho, Carolyn, Cook, Jack, Gamerman, Jamie, Goldsmith, Paul, Graaf, Piet H., Gurwitz, Jerry H., Haertter, Sebastian, Hilmer, Sarah, Huang, Shiew‐Mei, Inouye, Sharon K., Kanapuru, Bindu, Pirmohamed, Munir, Posner, Phil, Radziszewska, Barbara, Keipp Talbot, H., Temple, Robert

“…Changes that accompany older age can alter the pharmacokinetics (PK), pharmacodynamics (PD), and likelihood of adverse effects (AEs) of a drug. However, older…”
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Role of Clinical Pharmacology in Diversity and Inclusion in Global Drug Development: Current Practices and Industry Perspectives: White Paper by Sawant‐Basak, Aarti, Urva, Shweta, Mukker, Jatinder Kaur, Haertter, Sebastian, Mariano, Dean, Parasrampuria, Dolly A., Goteti, Kosalaram, Singh, Ravi Shankar Prasad, Chiney, Manoj, Liao, Michael Z., Chang, Sandy S., Mehta, Rashmi

“…The 2022 United States Food and Drug Administration (US FDA) draft guidance on diversity plan (DP), which will be implemented through the Diversity Action…”
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Dabigatran Etexilate in Atrial Fibrillation Patients With Severe Renal Impairment: Dose Identification Using Pharmacokinetic Modeling and Simulation by Lehr, Thorsten, Haertter, Sebastian, Liesenfeld, Karl-Heinz, Staab, Alexander, Clemens, Andreas, Reilly, Paul A., Friedman, Jeffrey

“…Dabigatran, administered orally as the prodrug dabigatran etexilate (DE), is a direct thrombin inhibitor shown to be effective in the prevention of stroke and…”
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A comparison of dabigatran etexilate with warfarin in patients with mechanical heart valves: The Randomized, phase II study to Evaluate the sAfety and pharmacokinetics of oraL dablGatran etexilate in patients after heart valve replacemeNt (RE-ALIGN) by VAN DE WERF, Frans, BRUECKMANN, Martina, NOACK, Herbert, EIKELBOOM, John W, CONNOLLY, Stuart J, FRIEDMAN, Jeffrey, GRANGER, Christopher B, HÄRTTER, Sebastian, HARPER, Ruth, KAPPETEIN, Arie Pieter, LEHR, Thorsten, MACK, Michael J

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Challenges and Opportunities in the Development of Medical Therapies for Pediatric Populations and the Role of Extrapolation by 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

“…Extrapolation can be used to address challenges in pediatric drug development. This review describes how these challenges could be addressed by further…”
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Safety, tolerability and clinical pharmacology of dabigatran etexilate in adolescents. An open-label phase IIa study by Halton, Jacqueline M L, Lehr, Thorsten, Cronin, Lisa, Lobmeyer, Maximilian T, Haertter, Sebastian, Belletrutti, Mark, Mitchell, Lesley G

“…Venous thromboembolism (VTE) incidence is increasing among children owing to many factors, including improved diagnosis of VTE. There is a need for alternative…”
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ICH M9 Guideline in Development on Biopharmaceutics Classification System-Based Biowaivers: An Industrial Perspective from the IQ Consortium by Bransford, Philip, Cook, Jack, Gupta, Manish, Haertter, Sebastian, He, Handan, Ju, Rob, Kanodia, Jitendra, Lennernäs, Hans, Lindley, David, Polli, James E, Wenning, Larissa, Wu, Yunhui

“…In October 2016, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) ICH began efforts to provide…”
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Pharmacometric Characterization of Dabigatran Hemodialysis by Liesenfeld, Karl-Heinz, Staab, Alexander, Härtter, Sebastian, Formella, Stephan, Clemens, Andreas, Lehr, Thorsten

“…Background Hemodialysis has been shown to be a useful method of decreasing dabigatran plasma levels in situations that require rapid elimination of this…”
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Pediatric Extrapolation in Type 2 Diabetes: Future Implications of a Workshop by Barrett, Jeffrey S., Bucci‐Rechtweg, Christina, Amy Cheung, S. Y., Gamalo‐Siebers, Margaret, Haertter, Sebastian, Karres, Janina, Marquard, Jan, Mulugeta, Yeruk, Ollivier, Cecile, Strougo, Ashley, Yanoff, Lisa, Yao, Lynne, Zeitler, Philip

“…Extrapolation from adults to youth with type 2 diabetes (T2D) is challenged by differences in disease progression and manifestation. This manuscript presents…”
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