한의학임상에 기초를 둔 천연물신약 연구과정에 대한 소고
A Proposal for Research Process of Botanical Drug based Clinical Traditional Korean Medicine
1
조회
0
다운로드
10
인용
0
참고문헌
키워드
초록
Purpose : To propose various types of clinical research which is feasible for botanical new drug (IND) development processes, and suggest essential steps to development of study protocol for IND. Methods : Literature-based discussions and one research group’s experience is given regarding domestic act, regulation, and system. Results : In order to get an approval of IND for botanical drug in Korea there are several types of clinical research to conduct. In quality control steps for standardized medicinal herbs, case reports or case series can be conducted, and for good manufacturing practice(GMP) steps, we can conduct case reports, case series, and retrospective cohort studies. In addition, as long as we gathered good laboratory practice(GLP) data we can conduct up to quasi-experimental studies and clinical trials including investigator initiated trials. In order to conduct these studies development of study protocol is essential. First, we obtain historical evidence including target disease and indication, efficacy, safety, and endpoints by reviewing medical classics. Second, we obtain clinically and statistically important data by conducting non-clinical studies, observation studies, and quasi-experimental studies. Third, we generate research hypotheses and purposes and explore methodologies, endpoints, clinical practice guidelines, cost-effectiveness, and commercial potential. Finally, we develop study protocol with aid of biostatistician or expert in contract research organization. Discussions and conclusions : This study have obvious limitations in that most thoughts, suggestions, and proposes are from one research group’s experience. Therefore, we hope to see various types of research in this topic and process from other research group as well.
Abstract
Purpose : To propose various types of clinical research which is feasible for botanical new drug (IND) development processes, and suggest essential steps to development of study protocol for IND. Methods : Literature-based discussions and one research group’s experience is given regarding domestic act, regulation, and system. Results : In order to get an approval of IND for botanical drug in Korea there are several types of clinical research to conduct. In quality control steps for standardized medicinal herbs, case reports or case series can be conducted, and for good manufacturing practice(GMP) steps, we can conduct case reports, case series, and retrospective cohort studies. In addition, as long as we gathered good laboratory practice(GLP) data we can conduct up to quasi-experimental studies and clinical trials including investigator initiated trials. In order to conduct these studies development of study protocol is essential. First, we obtain historical evidence including target disease and indication, efficacy, safety, and endpoints by reviewing medical classics. Second, we obtain clinically and statistically important data by conducting non-clinical studies, observation studies, and quasi-experimental studies. Third, we generate research hypotheses and purposes and explore methodologies, endpoints, clinical practice guidelines, cost-effectiveness, and commercial potential. Finally, we develop study protocol with aid of biostatistician or expert in contract research organization. Discussions and conclusions : This study have obvious limitations in that most thoughts, suggestions, and proposes are from one research group’s experience. Therefore, we hope to see various types of research in this topic and process from other research group as well.
참고문헌 (38)
- 엄석기, "전통한의학 연구방법론의 현대화에 대한 소고", 대한한의학원전학회지, 23(2), pp.89~105 (2010), 대한한의학원전학회
- 신현규, "旣成韓藥書 11종의 起源에 대한 書誌學的 根據와 改正 方案에 대한 硏究", 대한한의학원전학회지, 20(1), pp.103~112 (2007), 대한한의학원전학회
- 신현규, "한약 및 한약제제 관리와 연구개발 정책 방향에 관한 연구", 대한한의학회지, 21(2), pp.20~ (2000)
- 정희정, "국내 한방병원의 IRB 및 임상시험 실태조사", 대한한의학회지, 31(1), pp.122~129 (2010), 대한한의학회
- "약사법. 법률 제10324호. 일부개정 2010.05.27", ~ (2010)
- "의료법. 법률 제10325호. 일부개정 2010.05.27", ~ (2010)
- "의료기기법. 법률 제10326호. 일부개정 2010.05.27", ~ (2010)
- "건강기능식품에 관한 법률. 법률 제 10219호. 일부개정 2010.03.31", ~ (2010)
- "한의약육성법. 법률 제9932호(정부조직법). 일부개정 2010.01.18", ~ (2010)
- "천연물신약 연구개발 촉진법. 법률 제9932호(정부조직법). 일부개정 2010.01.18", ~ (2010)
- "의료법 시행규칙. 보건복지부령 제1호(보건복지부와 그 소속기관 직제 시행규칙). 일부개정 2010.03.19", ~ (2010)
- "의약외품범위지정. 보건복지가족부 고시 제2010-46호. 일부개정 2010.03.12", ~ (2010)
- "한약재 수급 및 유통관리 규정", 보건복지가족부고시 제2010-43호. 2010.03.10, ~ (2010)
- "기존한약서에 대한 잠정 규정", 보건복지가족부고시 제2008-175호. 2008.12.31, ~ (2008)
- "한약처방의 종류 및 조제방법에 관한 규정. 보건복지부 고시 제1995-15호. 개정 1995.03.15", ~ (1995)
- "의약품등의 품목허가 신고 심사규정", 식품의약품안전청 고시 제2010-37호. 2010.05.31., ~ (2010)
- "의약품 등의 안정성 시험 기준. 식품의약품안전청고시 제2009-117호. 개정 2009.08.24", ~ (2009)
- "비임상시험 관리 기준. 식품의약품안전청 고시제2009-183호. 개정 2009.12.22", ~ (2009)
- "의약품 임상시험 관리기준. 식품의약품안전청 고시제2009-211호. 개정 2009.12.22", ~ (2009)
- "의약품등 임상시험 실시기관 지정에 관한 규정.식품의약품안전청 고시 제2010-14호. 개정 2010.03.31", ~ (2010)
- "의약품 임상시험 계획 승인 지침. 식품의약품안전청고시 제2009-34호. 개정 2009.06.09", ~ (2009)
- "대한약전(제9개정판)", 식품의약품안전청 고시 제2007-89호. 개정 2007.12.28, ~
- "대한약전외생약규격집", 식품의약품안전청 고시제2007-90호. 개정 2007.12.28, ~
- "건강기능식품 기능성 원료 인정에 관한 규정", 식품의약품안전청 고시 제2009-176호. 개정 2009.12.22, ~ (2009)
- "건강기능식품에 사용할 수 없는 원료 등에 관한 규정", 식품의약품안전청 고시 제2010-16호.규정 2010.04.13, ~
- 식품의약품안전청 바이오생약국, "민원 질의 응답모음집 - 생약ㆍ한약 분야", 식품의약품안전청, 95~ (2009)
- 장승엽, "의약품 등의 품목허가ㆍ신고ㆍ심사 규정中 생약(한약)제제 분야 해설서", 식품의약품안전청, 16~28 (2009)
- 김기옥, "韓醫學通史", pp.203~ (2006), 대성의학사
- 이충열, "한의학의 과학화 그 역사와 반성", 한의신문, ~ (2009)
- 이충열, "정체성 담론은 개혁주의 산물: ‘한의학 없는과학화’ 진정한 개혁인가", 민족의학신문, ~ (2010)
- 이선동, "학생과 한의사들로부터 외면당하고 있는 한의학 교육과 연구: 한의계가 지금 해야할 일(5)", 한의신문, ~ (2009)
- 조병희, "한의학의 발전과 미래전망 (上)", 한의신문, ~ (2010)
- 조병희, "한의학의 발전과 미래전망 (下)", 한의신문, ~ (2010)
- "양한방관계와 통합의학의 전망"[URL]
- 식품의약품안전청, "보도자료 2010년 3월 17일.고령화 사회 맞아 천연물신약 개발 경쟁 심화", ~
- 식품의약품안전청, "보도자료 2010년 7월 13일.천연물신약 임상시험계획승인 신청시 이런 점참고하세요", ~
- "한약"[URL]
- "한약제제의 일반의약품 포함 여부"[URL]