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Guideline on specification and test methods information for HPV DNA chip new drug application
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- 발행기관
- 한국생물공학회 바로가기
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- 간행물
- 한국생물공학회 학술대회 바로가기
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- 통권
- 2007 춘계학술대회 및 국제심포지움 (2007.04)바로가기
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- 페이지
- pp.2-2
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- 저자
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- 언어
- 영어(ENG)
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- URL
- https://www.earticle.net/Article/A98502
※ 원문제공기관과의 협약기간이 종료되어 열람이 제한될 수 있습니다.
원문정보
초록
- 영어
- Biochip is defined as miniaturized test sites (microarrays) arranged on a solid substrate
that permits many tests to be performed at the same time in order to achieve higher throughput and speed. Biochip came out through Bio-technology and Information-technology. Over the past few years, korean government has supported biochip industry as a key sector in korea economy. As a consequence, biochip technology and industry has been in bloom since 2000. A number of research groups developed various types of biochips which are applicable to pharmaceutics/medicine as well as basic science, including environmental and biological field. Noticeably, biochip has been proven to be a powerful tool in diagnosing several diseases and is now expanding its share of market rapidly. KFDA has classified biochip as in-vitro diagnostic devices since 2003. While many kinds of diagnostic chips have been reviewed, HPV genotyping DNA chip is the first device to be approved by KFDA for its commercial use in July, 2004. Since then, other similar or upgraded HPV DNA chips has been approved. As with virus diagnostic chips, cancer diagnostic chips have been under developing and we hope these products will be on market in near future. Based on our experience on evaluating Specification and Test
Methods for HPV chips, we now published the new guideline which is intended as a reference for both developer and reviewer. This guideline basically propose the minimum requirement to evaluate the quality of HPV chips and several other documents may be required by reviewer when needed. While US FDA prepares the draft guideline for In-vitro multi-variate index assay, this guideline is the first one specific for HPV. KFDA hope that this guideline is a help for the companies, academic, research institute, and pharmaceutical company which are involved in In-Vitro diagnostic devices. Since this guidance represents the current thinking of KFDA, we are open to comment or advice from related areas.
저자
간행물 정보
발행기관
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- 발행기관명
- 한국생물공학회 [The Korean Society for Biotechnology and Bioengineering]
- 설립연도
- 1984
- 분야
- 공학>생물공학
- 소개
- 이 법인은 생물 공학의 발전과 보급에 이바지하고, 회원 상호 간의 연구 협력과 친목을 도모함을 목적으로 한다 1. 생물공학 분야의 발전을 위한 연구 협력 2. 생물공학의 실용화를 촉진시키기 위한 산학 협동 3. 학술연구 발표회, 강연회, 연수회 등 학술활동의 개최 4. 국,영문 학술지,소식지,학술회의 Proceedings 및 학술도서의 발간 5. 생물공학 발전을 위한 정책 건의 6. 기타 국제 교류 등 본 학회의 목적 달성을 위한 제반 활동
간행물
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- 간행물명
- 한국생물공학회 학술대회
- 간기
- 반년간
- 수록기간
- 1985~2013
- 십진분류
- KDC 476 DDC 576
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