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- 저자 : 진선경(Sun Kyung Jin) (검색결과 1 건)
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송윤경,진선경,한의식,안미령,정주연,이이다,조일영,김동섭,지은희,박효영,오정미,신원,이선희,김인규,Song, Yun-Kyoung,Jin, Sun-Kyung,Han, Eui-Sik,Ahn, Mee-Ryung,Jung, Ju-Yeon,Lee, Rhee-Da,Cho, Il-Yong,Kim, Dong-Sub,Ji, Eun-Hee,Park, Hyo-Young,Oh, 대한약학회 2011 약학회지 Vol.55 No.4
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.
ScienceON
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