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Drug Design, Development and Therapy Volume 11, 2017 - Issue

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Original Research

Failure mode and effects analysis drastically reduced potential risks in clinical trial conduct

Howard Lee1 Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital;2 Department of Transdisciplinary Studies, Graduate School of Convergence Science and Technology, Seoul National UniversityCorrespondence[email protected]

Heechan Lee1 Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital;2 Department of Transdisciplinary Studies, Graduate School of Convergence Science and Technology, Seoul National University

Jungmi Baik3 Clinical Trials Center, Seoul National University Hospital, Seoul, Republic of Korea

Hyunjung Kim3 Clinical Trials Center, Seoul National University Hospital, Seoul, Republic of Korea

Rachel Kim4 Global Clinical Trial Execution, Pfizer Korea, Seoul, Republic of Korea

Pages 3035-3043 | Published online: 19 Oct 2017

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Shuangshuang Lv, Yingqian Sun, Jian Zhang, Tingting Jin & Xiaxuan Hu. (2023) Application of the FMEA Method in Improving the Quality Management of Emergency Complete Blood Count Testing. Laboratory Medicine.
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Yong Seon Song, Eun Ju Kim, Eu Jin Chung, Byoung Hoon Ko, Hyun A Choi, Hye Young Ha, Hyun Ji Jo, Seong Kyu Baek, Eun Sook Jung, Mi Kyung Um, Mi Ran Park & Eun Kyoung Shon. (2022) Prevention of Medication Error by Failure Mode and Effects Analysis. Journal of Korean Society of Health-System Pharmacists 39:3, pages 355-367.
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Elena Bartolomé & Paula Benítez. (2021) Failure mode and effect analysis (FMEA) to improve collaborative project-based learning: Case study of a Study and Research Path in mechanical engineering. International Journal of Mechanical Engineering Education 50:2, pages 291-325.
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Giovanna L. Liguori & Annamaria Kisslinger. (2022) Quality Management Tools on the Stage: Old but New Allies for Rigor and Standardization of Extracellular Vesicle Studies. Frontiers in Bioengineering and Biotechnology 10.
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Xiao-Lan Shao, Ya-Zhou Wang, Xiong-Hui Chen & Wen-Juan Ding. (2022) Impact of failure mode and effects analysis-based emergency management on the effectiveness of craniocerebral injury treatment. World Journal of Clinical Cases 10:2, pages 554-562.
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Mauro Petretta, Giovanna Desando, Brunella Grigolo & Livia Roseti. (2021) Cartilage Tissue Engineering by Extrusion Bioprinting: Process Analysis, Risk Evaluation, and Mitigation Strategies. Materials 14:13, pages 3528.
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A. Mascia, A. M. Cirafici, A. Bongiovanni, G. Colotti, G. Lacerra, M. Di Carlo, F. A. Digilio, G. L. Liguori, A. Lanati & A. Kisslinger. (2020) A failure mode and effect analysis (FMEA)-based approach for risk assessment of scientific processes in non-regulated research laboratories. Accreditation and Quality Assurance 25:5-6, pages 311-321.
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Narendra Chirmule, Ravindra Khare, Atul Khandekar & Vibha Jawa. (2020) Failure Mode and Effects Analysis (FMEA) for Immunogenicity of Therapeutic Proteins. Journal of Pharmaceutical Sciences 109:10, pages 3214-3222.
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Hu‐Chen Liu, Li‐Jun Zhang, Ye‐Jia Ping & Liang Wang. (2019) Failure mode and effects analysis for proactive healthcare risk evaluation: A systematic literature review. Journal of Evaluation in Clinical Practice 26:4, pages 1320-1337.
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Li Zhang, Ling Zeng, Yuanting Yan & Qinwen Hang. (2019) Application of the healthcare failure mode and effects analysis system to reduce the incidence of posture syndrome of thyroid surgery. Medicine 98:51, pages e18309.
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Hu-Chen LiuHu-Chen Liu. 2019. Improved FMEA Methods for Proactive Healthcare Risk Analysis. Improved FMEA Methods for Proactive Healthcare Risk Analysis 15 45 .

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Failure mode and effects analysis drastically reduced potential risks in clinical trial conduct

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