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How to Optimize Healthy Volunteer Screening and Enrolment in Clinical Trials: A Qualitative and Quantitative Approach to Evaluate Processes and Healthy Volunteers' Perceptions
作者Evelyn Krohmer; Manuela König; Cathrin J. Vogt; Marina Streckebein; Sybille Baumann; Max Blumenstock; Ruwen Böhm; Fabian Müller; Nadja Struß; Viktoria S. Wurmbach; Antje Blank
作者单位1. Internal Medicine IX, Department of Clinical Pharmacology and Pharmacoepidemiology Medical Faculty Heidelberg University/Heidelberg University Hospital Heidelberg Germany; 2. CRS hVIVO Mannheim Germany; 3. CRS Berlin Germany; 4. Institute of Medical Informatics Heidelberg University Heidelberg Germany; 5. Socratec Erfurt Germany; 6. Boehringer Ingelheim Pharma GmbH & Co. KG Biberach an der Riß Germany; 7. Institute of Experimental and Clinical Pharmacology and Toxicology Friedrich‐Alexander‐Universität Erlangen‐Nürnberg Erlangen Germany
Phase I Evaluation of Siltartoxatug, a First‐in‐Class Anti‐Tetanus Monoclonal Antibody: Safety, Pharmacokinetics and Pharmacodynamics in Healthy Australian and Chinese Populations
作者Xinyu Liu; Zhigang Liu; Xiaohu Kuang; Yueming Wang; Xiaoyi Liu; Jiyuan Ding; Xia Zhou; Xin Zhou; Qianyu Liang; Meizhuo Zhang; Hao Zhao; Qingqing Tan; Weihong Zheng; Huaxin Liao; Charlotte Lemech; Wanmei Wang
作者单位1. Zhuhai Trinomab Pharmaceutical Co., Ltd. Zhuhai China; 2. The Fifth Affiliated Hospital Sun Yat‐sen University Zhuhai China; 3. Present address: Cancer Center, The Tenth Affiliated Hospital Southern Medical University (Dongguan People's Hospital) Dongguan China; 4. Scientia Clinical Research Ltd. Sydney Australia
Exposure–Response Analysis of Enfortumab Vedotin Plus Pembrolizumab as First‐Line Therapy for Locally Advanced or Metastatic Urothelial Cancer
作者Vaishali L. Chudasama; Helen Kastrissios; Hossam Kadry; Daping Zhang; Salaheldin Hamed; Srinivasu Poondru; Souvik Bhattacharya; Russ Wada; Amit Garg; Yen Lin Chia
作者单位1. Pfizer Inc New York New York USA; 2. QuanTx Consulting Mountain View California USA; 3. Astellas Pharma Northbrook Illinois USA; 4. BeOne Medicines San Carlos California USA
Effects of Fomepizole on Acetaminophen Oxidative Metabolism: A Randomized, Crossover Study in Human Volunteers
作者Sidharth Anand; Nicholas A. Buckley; Paul Stathakis; Laura James; Larry Parker; Mitchell R. McGill; Angela L Chiew
作者单位1. Faculty of Medicine The University of New South Wales Sydney New South Wales Australia; 2. Faculty of Medicine and Health The University of Sydney Camperdown New South Wales Australia; 3. NSW Health Pathology, Prince of Wales Hospital Randwick New South Wales Australia; 4. Department of Pediatrics, College of Medicine University of Arkansas for Medical Sciences Little Rock Arkansas USA; 5. Acetaminophen Toxicity Diagnostics, LLC Little Rock Arkansas USA; 6. Department of Environmental Health Sciences, Fay W. Boozman College of Public Health University of Arkansas for Medical Sciences Little Rock Arkansas USA; 7. Department of Pharmacology and Toxicology, College of Medicine University of Arkansas for Medical Sciences Little Rock Arkansas USA; 8. Department of Clinical Toxicology Prince of Wales Hospital Randwick New South Wales Australia
Epcoritamab Step‐Up Dosing Regimen Selection and Optimization Using Repeated Time‐to‐Event Modeling for Cytokine Release Syndrome Risk Mitigation
作者Tommy Li; Andrew Tredennick; Daniel Polhamus; Matthew Putnins; Sihang Liu; Kinjal Sanghavi; Craig J. Thalhauser; Apurvasena Parikh; Behnam Noorani; Mohamed‐Eslam F. Mohamed; Chris Le Gallo; Brian Elliott; Manish Gupta; Steven Xu
作者单位1. Genmab Princeton New Jersey USA; 2. Metrum Research Group Boston Massachusetts USA; 3. AbbVie Inc. North Chicago Illinois USA
Symposium Report: Stakeholders' Perspectives on Phase 1 Trials in Japanese Prior to Multi‐Regional Clinical Trials and Future Pathways
作者Yosuke Kobayashi; Nobuko Matsushima; Noriyuki Takai; Daisuke Sato; Shinichiro Hoshino; Akihiro Ishiguro; Yasuo Iimura
作者单位1. Pharmaceuticals and Medical Devices Agency Tokyo Japan; 2. Johnson & Johnson J&J Innovative Medicine Tokyo Japan; 3. Drug Evaluation Committee Japan Pharmaceutical Manufacturers Association Tokyo Japan; 4. EPS Corporation Tokyo Japan; 5. Ministry of Health, Labour and Welfare Tokyo Japan; 6. Eli Lilly Japan K.K. Kobe Japan
Resolving CYP2D6 Structural Complexity with Long‐Read Sequencing: Implications for Tamoxifen Precision Dosing in Thai Breast Cancer Patients
作者Usa Boonyuen; Sirinyatorn Talukam; Beatriz Aira C. Jacob; Wayu Matphong; Kamonwan Chamchoy; Onrapak Reamtong; Nuntana Meesiripan; Junya Yamagishi; Matthew Phanchana; Chayanoot Rattadilok
作者单位1. Department of Molecular Tropical Medicine and Genetics, Faculty of Tropical Medicine Mahidol University Bangkok Thailand; 2. Princess Srisavangavadhana Faculty of Medicine Chulabhorn Royal Academy Bangkok Thailand; 3. National Cancer Institute Bangkok Thailand; 4. International Institute for Zoonosis Control Hokkaido University Hokkaido Japan
Risk of Hyperkalemia in Patients with Heart Failure Treated with Spironolactone in Combination with Sacubitril/Valsartan vs. Renin–Angiotensin System Inhibitors
作者Katherine L. Crum; Muthiah Vaduganathan; Rishi J. Desai
作者单位1. Department of Epidemiology Harvard T.H. Chan School of Public Health Boston Massachusetts USA; 2. Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine Brigham and Women's Hospital and Harvard Medical School Boston Massachusetts USA; 3. Division of Cardiovascular Medicine Brigham and Women's Hospital Boston Massachusetts USA
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