상세검색
최근 검색어 전체 삭제
다국어입력
즐겨찾기0
158498.jpg
KCI등재후보 학술저널

재심사 대상 의약품의 시판 후 조사 질 관리에 대한 연구

The Quality Control of Post-Authorization Study of Re-Examination in Korea

  • 2

BACKGROUND Re-examination system was post-marketing safety measures for drugs in Korea. The objective of this study was to examine experts’ opinions for post-authorization study and current status of quality control of study in pharmaceutical company to improve the quality of post-authorization study of re-examination. METHODS We conducted mail survey for pharmaceutical company (2014. 9. 15-10. 17) and e-mail survey for experts (2014. 10. 1-10. 17). Questionnaires for 29 pharmaceutical companies and for 19 experts were collected and analyzed. RESULTS More than 80% of experts said that quality control of post-authorization study is needed to improve the study, however, many pharmaceutical companies had a difficulty in conducting study. Seventy two percent of companies pointed out low cooperation of survey sites as difficulty in monitoring of post-authorization study. CONCLUSION Quality control of post-authorization study of re-examination system needs to be improved to provide reliable evidence for drug safety.

연구방법

연구결과

고 찰

감사의 말씀

참고문헌

로딩중