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KMID : 0370220110550040345
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Yakhak Hoeji
2011 Volume.55 No. 4 p.345 ~ p.351
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Guideline for the Clinical Trials Evaluation for Gastritis
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Song Yun-Kyoung
Han Eui-Sik
Jung Ju-Yeon
Lee Rhee-Da
Cho Il-Yong
Kim Dong-Sub
Jin Sun-Kyung
Ahn Mee-Ryung
Shin Won
Lee Sun-Hee
Ji Eun-Hee
Park Hyo-Young
Oh Jung-Mi
Kim In-Kyu
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Abstract
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Gastritis is the most common disease among Korean. The demand for the development of gastritis drugs has been increasing. Currently, however, there is no guideline available for the clinical evaluation of gastritis drugs worldwide. As a consequence, domestic and international pharmaceutical companies make errors in the drug development processes, and it becomes difficult for them to establish the scientific validity and objectivity of newly developed drugs. The objective of this study was to develop the Guideline for Clinical Trials Evaluation of Gastritis which can be used in improving the quality and consistency of clinical trials. First, we collected and reviewed the clinical trials on gastritis drugs that were available from Japan Pharmaceuticals and Medical Devices Agency and Korea Food and Drug Administration (KFDA), and investigated the recent research trends on clinical trials of gastritis drugs. Reviewers from KFDA and National Institute of Food and Drug Safety Evaluation and scientific experts from the pharmaceutical industries developed the guidelines through regularly scheduled meetings. Opinions and consultation from academic fields and industry experts were also obtained. This project will provide the clinical trial practitioners, investigator and reviewers the scientific and rational guidelines for performance and evaluation of clinical trials for gastritis drugs. Furthermore, we hope this guideline contributes to establishing the national competitiveness, improving the quality of clinical trial, and encouraging researches on drug development for gastritis.
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KEYWORD
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gastritis, clinical trial, guideline
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