YAKHAK HOEJI (약학회지)

The Pharmaceutical Society of Korea (대한약학회)
권호 표지

Guideline for the Clinical Trials Evaluation for Gastritis

위염치료제의 임상시험평가지침 연구

  • Song, Yun-Kyoung (Pharmaceuticals and Medical Devices Research Department, National Institute of Food and Drug Safety Evaluation, Korea Food and Drug Administration) ;
  • Jin, Sun-Kyung (Drug Evaluation Department, Korea Food and Drug Administration) ;
  • Han, Eui-Sik (Pharmaceuticals and Medical Devices Research Department, National Institute of Food and Drug Safety Evaluation, Korea Food and Drug Administration) ;
  • Ahn, Mee-Ryung (Drug Evaluation Department, Korea Food and Drug Administration) ;
  • Jung, Ju-Yeon (Pharmaceuticals and Medical Devices Research Department, National Institute of Food and Drug Safety Evaluation, Korea Food and Drug Administration) ;
  • Lee, Rhee-Da (Pharmaceuticals and Medical Devices Research Department, National Institute of Food and Drug Safety Evaluation, Korea Food and Drug Administration) ;
  • Cho, Il-Yong (Pharmaceuticals and Medical Devices Research Department, National Institute of Food and Drug Safety Evaluation, Korea Food and Drug Administration) ;
  • Kim, Dong-Sub (Pharmaceuticals and Medical Devices Research Department, National Institute of Food and Drug Safety Evaluation, Korea Food and Drug Administration) ;
  • Ji, Eun-Hee (College of Pharmacy, Seoul National University) ;
  • Park, Hyo-Young (College of Pharmacy, Seoul National University) ;
  • Oh, Jung-Mi (College of Pharmacy, Seoul National University) ;
  • Shin, Won (Drug Evaluation Department, Korea Food and Drug Administration) ;
  • Lee, Sun-Hee (Drug Evaluation Department, Korea Food and Drug Administration) ;
  • Kim, In-Kyu (Pharmaceuticals and Medical Devices Research Department, National Institute of Food and Drug Safety Evaluation, Korea Food and Drug Administration)
  • 송윤경 (식품의약품안전평가원 의료제품연구부) ;
  • 진선경 (식품의약품안전청 의약품심사부) ;
  • 한의식 (식품의약품안전평가원 의료제품연구부) ;
  • 안미령 (식품의약품안전청 의약품심사부) ;
  • 정주연 (식품의약품안전평가원 의료제품연구부) ;
  • 이이다 (식품의약품안전평가원 의료제품연구부) ;
  • 조일영 (식품의약품안전평가원 의료제품연구부) ;
  • 김동섭 (식품의약품안전평가원 의료제품연구부) ;
  • 지은희 (서울대학교 약학대학) ;
  • 박효영 (서울대학교 약학대학) ;
  • 오정미 (서울대학교 약학대학) ;
  • 신원 (식품의약품안전청 의약품심사부) ;
  • 이선희 (식품의약품안전청 의약품심사부) ;
  • 김인규 (식품의약품안전평가원 의료제품연구부)
  • Received : 2011.06.08
  • Accepted : 2011.07.06
  • Published : 2011.08.31
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Abstract

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.

Keywords

References

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