Sessions

Development of New Trial Protocol Development Process Chart using Quality by Design method

[Speaker] Kotone Matsuyama:1,10
[Co-author] Kouji Iwasaki:2, Noriaki Nagao:3, Yukiko Matsushima:4, Hiroshi Hayashi:5, Shoji Sanada:6, Yuki Suzaki:7, Goshi Ozawa:8, Takuhiro Yamaguchi:9, Naoto Uemura:10
1:Department of Health Policy and Management, Nippon Medical School, Japan, 2:Academic Clinical Research Center, Department of Medical Innovation, Osaka University Hospital, Japan, 3:Japan Tobacco Inc., Japan, 4:Clinical Research Department, Clinical and Translational Research Center, Keio University Hospital, Japan, 5:Hokkaido University Hospital, Japan, 6:Department of Cardiovascular Medicine, Osaka University Hospital, Japan, 7:Takeda Pharmaceutical Company Ltd., Japan, 8:Real Discovery Outdoors Co. Ltd., Japan, 9:Department of Public Health and Forensic Medicine, Graduate School of Medicine, Tohoku University, Japan, 10:Department of Clinical Pharmacology & Therapeutics, Faculty of Medicine, Oita University, Japan

Dialogue first: Implementation of a phase 1 unit in Argentina under a new regulatory setting

[Speaker] Ventura A Simonovich:1
[Co-author] Cintia V Cruz:1,2, Mariana G Fernandez:2, Paula Scibona:1, Valeria Beruto:1, Waldo H Belloso:1
1:Sección Farmacología Clínica - Clínica médica, Hospital Italiano de Buenos Aires, Argentina, 2:II Unidad académica de Farmacología, Argentina

Drug approval in India does not match the disease burden: A cross-sectional study

[Speaker] Jaykaran Charan:1
[Co-author] Jatin V Dhanani:2, Maulik S Doshi:3, Tea Reljic:4, Athanasios Tsalatsanis:4, Ambuj Kumar:4
1:Pharmacology, Department of Pharmacology, All India Institute of Medical Sciences, Jodhpur, India, 2:Dept of Pharmacology, GMERS Medical College, Valsad (Gujarat), India, 3:Dept of Clinical Pharmacology, KEM Hospital, Mumbai, India, 4:USF Health Program for Comparative Effectiveness Research and Evidence Based Medicine, University of South Florida, Tampa, Florida, USA

Clinical trial activation via a newly developed clinical department network

[Speaker] Yusuke Endo:1
[Co-author] Chika Yamamoto:1, Hiroshi Sunada:1, Miki Shimada:1, Atsushi Takenaka:1
1:Advanced Medicine, Innovation and Clinical Research Center, Tottori University Hospital, Japan

MICRODOSING/MICROTRACING CLINICAL TRIALS USING ACCELERATED MASS SPECTROMETRY IN CLINICAL DRUG DEVELOPMENT

[Speaker] Mu Seong Ban:1
[Co-author] Jun Gi Hwang:1, Jae Hoon Shim:2, Anhye Kim:3, Joo-Youn Cho:1, Howard Lee:1,4
1:Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Korea, 2:Korea Institute of Radiological & Medical Sciences, Korea, 3:Clinical Trial Center, Ajou University Medical Center, Korea, 4:Department of Transdisciplinary Studies, Graduate School of Convergence Science and Technology, Seoul National University, Korea

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