Studies on the Variation in Clinical Laboratory Data and Safety Evaluation of Pharmaceuticals
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概要
- 論文の詳細を見る
The safety of pharmaceuticals has become increasingly important not only in daily medical treatment but also in clinical trials. Although clinical laboratory data are more objective than clinical symptoms, the determination as to whether they indicate abnormal variations depends largely upon the clinical judgment of physicians. The process of determination has not been sufficiently objectified. The present study investigated the indices of criteria for variations in clinical laboratory data obtained in clinical trials. Then, detection rates of abnormal variations were compared between our determination method that employs the reference change value (RCV) expressing the width of biological variation for each test component and conventional determination methods. The study also demonstrated that by combining standard values and the RCV for determination, abnormal variations were found at a rate greater than 50%. The method we propose was applied to the safety evaluation of pharmaceuticals. In clinical trials on the antiviral drug ribavirin administered alone, components of laboratory tests were selected that should be noted in studies on its effects. Expect for decreases in red blood cell counts and hemoglobin values, which are closely associated with anemic symptoms and well known to hepatologists, the increasing trend in platelet counts and decreasing trend in albumin were found to be laboratory test components that should be paid attention to, even though they may not be obvious.
- 公益社団法人日本薬学会の論文
- 2005-12-01
著者
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MORIYAMA Kenzo
Department of Pharmacy, Kinki University Hospital
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KUDO Masatoshi
Department of Gastroenterology, Kinki University Medical School of Medicine
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Moriyama Kenzo
Department Of Pharmacy Kinki University Hospital
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Moriyama Kenzo
Department Of Hospital Pharmacy School Of Medicine Kinki University
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Kaneko H
Department Of General Surgical Science (surgery I) Graduate School Of Medicine Gunma University
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Kato Hiroyuki
Department Of General Surgical Science And 21st Century Coe Program Graduate School Of Medicine Gunm
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Kuwano Hiroyuki
Department Of Pharmacy Kinki University Hospital
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HATA Taeko
Department of Pharmacology, Faculty of Pharmaceutical Sciences, Kinki University
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FUKUOKA Masahiro
Department of Respiratory Diseases, Osaka City General Hospital
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TOHDA Yuji
Department of Respiratory Medicine and Allergology, Kinki University School of Medicine
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NOMURA Morihiro
Departments of Pharmacy, Kinki University Hospital
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NAITOH Shouchi
Department of Clinical Laboratory
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KUWAO Hiroyuki
Departments of Pharmacy, Kinki University Hospital
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Hata Taeko
Faculty of Pharmaceutical Science, Kinki University
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Kuwano Hiroyuki
Department Of General Surgical Science Graduate School Of Medicine Gunma University
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Hata Taeko
Faculty Of Pharmaceutical Science Kinki University
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Hata Taeko
Department Of Pharmacology Faculty Of Pharmaceutical Sciences Kinki University
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Tohda Yuji
Department Of Pharmacy Kinki University Hospital
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Naitoh Shouchi
Department Of Clinical Laboratory:department Of Clinical Trial Management Center Kinki University Ho
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Kudo Masatoshi
Department Of Gastroenterology And Hepatology Kinki University School Of Medicine
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Kudo Masatoshi
Kinki Univ. School Of Medicine Osaka Jpn
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Fukuoka Masahiro
Departments Of Medical Oncology
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Fukuoka Masahiro
Department Of Cardiology National Sagamihara Hospital
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Nomura Morihiro
Department Of Pharmacy Kinki University Hospital
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Kuwano Hiroyuki
Department Of General Surgical Science And 21st Century Coe Program Graduate School Of Medicine Gunm
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Kuwano Hiroyuki
Department Of General Surgical Science Gunma University School Of Medicine
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Kudo Masatoshi
Department Of Gastroenterology And Hepatology Kinki University Faculty Of Medicine
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野村 守弘
Departments of Pharmacy, Kinki University Hospital
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秦 多恵子
Department of Pharmacology, Faculty of Pharmaceutical Sciences, Kinki University
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内藤 昭智
Department of Clinical Laboratory
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桑野 寛行
Departments of Pharmacy, Kinki University Hospital
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森山 健三
Departments of Pharmacy, Kinki University Hospital
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福岡 正博
Departments of Medical Oncology
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工藤 正俊
Department of Gastroenterology and Hepatology, Kinki University School of Medicine
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東田 有智
Departments of Pharmacy, Kinki University Hospital
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工藤 正俊
Department of Gastroenterology and Hepatology, Kinki University Faculty of Medicine
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