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Stefan Willmann

us food & drug administration (fda)

37H指数
119论文数
5.0K被引数
收录论文 36
发表时间
Physiologically-Based Pharmacokinetic Modeling to Support Pediatric Clinical Development: An IQ Working Group Perspective on the Current Status and Challenges基于生理学的药代动力学建模以支持儿科临床开发:IQ工作组关于当前状况和挑战的观点
err2025-11-01
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errYates, James W. T.; Zientek, Michael; Taskar, Kunal S.; Lin, Wen; Heimbach, Tycho; Willmann, Stefan; Rehmel, Jessica; Parrott, Neil; Hanley, Michael; Badee, Justine; Chen, Yuan; Cole, Susan; De Zwart, Loeckie; Haertter, Sebastian; Jiang, Rongrong; Kotsuma, Masakatsu; Liang, Guiqing; Lin, Yu-Wei; Liu, Jing; Ou, Ying; Rascher, Juliane; Shaik, Naveed A.; Wahlstrom, Jan; Wang, Xiaofeng; Xiao, Guangqing; Yee, Ka Lai; Cheung, S. Y. Amy
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Population pharmacokinetic-pharmacodynamic model of elinzanetant based on integrated clinical phase I and II data
err2024-09-18
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errWillmann, Stefan; Lloyd, Adam; Austin, Rupert; Joseph, Shiju; Solms, Alexander; Zhang, Yang; Schneider, Annika R. P.; Frechen, Sebastian; Schultze-Mosgau, Marcus-Hillert
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A Phase II randomized controlled trial evaluated antithrombotic treatment with fesomersen in patients with kidney failure on hemodialysis
err2024-07-01
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PREAI
errWinkelmayer, Wolfgang C.; Lensing, Anthonie W. A.; Thadhani, Ravi I.; Mahaffey, Kenneth W.; Walsh, Michael; Pap, Akos F.; Willmann, Stefan; Thelen, Kirstin; Hodge, Sophie; Solms, Alexander; Ingham, Sheila J. M.; Eikelboom, John
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Pharmacokinetics, pharmacodynamics, and safety of fesomersen, a novel antisense inhibitor of factor XI, in healthy Chinese, Japanese, and Caucasian volunteers
err2024-04-02
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errLiu, Tianxing; Hashizume, Kensei; Krieg, Eva; Chen, Huijun; Mukaida, Yuki; Thelen, Kirstin; Friedrichs, Frauke; Willmann, Stefan; Schwers, Stephan; Solms, Alexander; Yu, Rosie
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Longitudinal observations of TFPI levels in paediatric Haemophilia A patients
err2023-06-19
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PREAI
errSchwers, Stephan; Shah, Anita; Linardi, Camila; Zhang, Yang; Willmann, Stefan
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Anticoagulation in pediatric cancer-associated venous thromboembolism: a subgroup analysis of EINSTEIN-Jr
err2022-11-22
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errPalumbo, Joseph S.; Lensing, Anthonie W. A.; Brandao, Leonardo R.; Hooimeijer, Helene L.; Kenet, Gili; van Ommen, Heleen; Pap, Akos F.; Majumder, Madhurima; Kubitza, Dagmar; Thelen, Kirstin; Willmann, Stefan; Prins, Martin H.; Monagle, Paul; Male, Christoph
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Model-informed bridging of rivaroxaban doses for thromboprophylaxis in pediatric patients aged 9 years and older with congenital heart disease
err2022-06-14
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errWillmann, Stefan; Ince, Ibrahim; Ahsman, Maurice; Coboeken, Katrin; Zhang, Yang; Thelen, Kirstin; Kubitza, Dagmar; Zannikos, Peter; Zhou, Wangda; Pina, Liza Miriam; Post, Teun; Lippert, Joerg
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Riociguat for the treatment of Phe508del homozygous adults with cystic fibrosis
err2021-11-01
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errDerichs, Nico; Taylor-Cousar, Jennifer L.; Davies, Jane C.; Fajac, Isabelle; Tullis, Elizabeth; Nazareth, Dilip; Downey, Damian G.; Rosenbluth, Daniel; Malfroot, Anne; Saunders, Clare; Jensen, Renee; Solomon, George M.; Vermeulen, Francois; Kaiser, Andreas; Willmann, Stefan; Saleh, Soundos; Droebner, Karoline; Sandner, Peter; Bear, Christine E.; Hoffmann, Anja; Ratjen, Felix; Rowe, Steven M.
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Clinical investigation of the biopharmaceutical characteristics of nifurtimox tablets-Implications for quality control and application
err2021-11-01
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errStass, Heino; Just, Sarah; Weimann, Boris; Ince, Ibrahim; Willmann, Stefan; Feleder, Ethel; Freitas, Cecilia; Yerino, Gustavo; Muenster, Uwe
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Population pharmacokinetic analysis of rivaroxaban in children and comparison to prospective physiologically-based pharmacokinetic predictions
err2021-08-23
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errWillmann, Stefan; Coboeken, Katrin; Zhang, Yang; Mayer, Hannah; Ince, Ibrahim; Mesic, Emir; Thelen, Kirstin; Kubitza, Dagmar; Lensing, Anthonie W. A.; Yang, Haitao; Zhu, Peijuan; Mueck, Wolfgang; Drenth, Henk-Jan; Lippert, Joerg
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PK/PD modeling of FXI antisense oligonucleotides to bridge the dose-FXI activity relation from healthy volunteers to end-stage renal disease patients
err2021-06-23
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errWillmann, Stefan; Marostica, Eleonora; Snelder, Nelleke; Solms, Alexander; Jensen, Markus; Lobmeyer, Maximilian; Lensing, Anthonie W. A.; Bethune, Claudette; Morgan, Erin; Yu, Rosie Z.; Wang, Yanfeng; Jung, Shiangtung W.; Geary, Richard; Bhanot, Sanjay
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Rivaroxaban for treatment of pediatric venous thromboembolism. An Einstein-Jr phase 3 dose-exposure-response evaluation
err2020-07-01
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errYoung, Guy; Lensing, Anthonie W. A.; Monagle, Paul; Male, Christoph; Thelen, Kirstin; Willmann, Stefan; Palumbo, Joseph S.; Kumar, Riten; Nurmeev, Ildar; Hege, Kerry; Bajolle, Fanny; Connor, Philip; Hooimeijer, Helene L.; Torres, Marcela; Chan, Anthony K. C.; Kenet, Gili; Holzhauer, Susanne; Santamaria, Amparo; Amedro, Pascal; Beyer-Westendorf, Jan; Martinelli, Ida; Massicotte, M. Patricia; Smith, William T.; Berkowitz, Scott D.; Schmidt, Stephan; Price, Victoria; Prins, Martin H.; Kubitza, Dagmar
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Bodyweight-adjusted rivaroxaban for children with venous thromboembolism (EINSTEIN-Jr): results from three multicentre, single-arm, phase 2 studies
err2019-10-01
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PREAI
errMonagle, Paul; Lensing, Anthonie W. A.; Thelen, Kirstin; Martinelli, Ida; Male, Christoph; Santamaria, Amparo; Samochatova, Elena; Kumar, Riten; Holzhauer, Susanne; Saracco, Paola; Simioni, Paolo; Robertson, Jeremy; Grangl, Gernot; Halton, Jacqueline; Connor, Phillip; Young, Guy; Molinari, Angelo C.; Nowak-Goettl, Ulrike; Kenet, Gili; Kapsa, Stefanie; Willmann, Stefan; Pap, Akos F.; Becka, Michael; Twomey, Teresa; Beyer-Westendorf, Jan; Prins, Martin H.; Kubitza, Dagmar
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Application of Physiologically-Based and Population Pharmacokinetic Modeling for Dose Finding and Confirmation During the Pediatric Development of Moxifloxacin
err2019-08-07
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errWillmann, Stefan; Frei, Matthias; Sutter, Gabriele; Coboeken, Katrin; Wendl, Thomas; Eissing, Thomas; Lippert, Jorg; Stass, Heino
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Enhancing the Quality of Rivaroxaban Exposure Estimates Using Prothrombin Time in the Absence of Pharmacokinetic Sampling
err2019-07-05
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errSolms, Alexander; Frede, Matthias; Berkowitz, Scott D.; Hermanowski-Vosatka, Anne; Kubitza, Dagmar; Mueck, Wolfgang; Spiro, Theodore E.; Willmann, Stefan; Yan, Xiaoyu; Zhang, Liping; Garmann, Dirk
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Comment on model-based meta-analysis to evaluate optimal doses of direct oral factor Xa inhibitors in atrial fibrillation patients
err2018-11-27
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errWillmann, Stefan; Zhang, Liping; Mayer, Hannah; Siegmund, Hans-Ulrich; Tanigawa, Takahiko; Kaneko, Masato; Peters, Gary; Weitz, Jeffrey I.; Berkowitz, Scott D.; Burghaus, Rolf
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Integrated Population Pharmacokinetic Analysis of Rivaroxaban Across Multiple Patient Populations
err2018-04-16
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errWillmann, Stefan; Zhang, Liping; Frede, Matthias; Kubitza, Dagmar; Mueck, Wolfgang; Schmidt, Stephan; Solms, Alexander; Yan, Xiaoyu; Garmann, Dirk
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Evaluation of changes in oral drug absorption in preterm and term neonates for Biopharmaceutics Classification System (BCS) class I and II compounds
err2015-10-30
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errSomani, Amit A.; Thelen, Kirstin; Zheng, Songmao; Trame, Mirjam N.; Coboeken, Katrin; Meyer, Michaela; Schnizler, Katrin; Ince, Ibrahim; Willmann, Stefan; Schmidt, Stephan
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