위염치료제의 임상시험평가지침 연구

• 영문명: Guideline for the Clinical Trials Evaluation for Gastritis
• 발행기관: 대한약학회
• 저자명: 송윤경(Yun Kyoung Song) 진선경(Sun Kyung Jin) 한의식(Eui Sik Han) 안미령(Mee Ryung Ahn) 정주연(Ju Yeon Jung) 이이다(Rheeda Lee) 조일영(Il Yong Cho) 김동섭(Dong Sub Kim) 지은희(Eun Hee Ji) 박효영(Hyo Young Park) 오정미(Jung Mi Oh) 신원(Won Shin) 이선희(Sun Hee Lee) 김인규(In Kyu Kim)
• 간행물 정보: 『약학회지』제55권 제4호 (2011년), 1~26쪽, 전체 26쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2011.08.30

영문 초록

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.

키워드

gastritis clinical trial guideline