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A New Way in Deciding NOAEL Based on the Findings from GLP-Toxicity Test
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  • A New Way in Deciding NOAEL Based on the Findings from GLP-Toxicity Test
  • A New Way in Deciding NOAEL Based on the Findings from GLP-Toxicity Test
저자명
Park. Yeong-Chul,Cho. Myung-Haing
간행물명
Toxicological research
권/호정보
2011년|27권 3호|pp.133-135 (3 pages)
발행정보
한국독성학회
파일정보
정기간행물|ENG|
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
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기타언어초록

The FDA guidance focuses on the use of the NOAEL to establish the maximum recommended starting dose. The majority of NOAEL has been described inaccurately or incompletely in final reports for 90-days repeated dose toxicity test based on GLP (good laboratory practice) regulation. This is the most serious one of reasons for why most pharmaceutical companies targeting global markets have disregarded the final report produced from GLP facilities in Korea. The problems in deciding NOAEL reflected in the final reports are mainly due to the followings; 1) Inaccurate description or use of NOEL, NOAEL and LOAEL, 2) Insufficient and inappropriate interpretations in findings from toxicity test. This paper is intended to provide the insight into distinguishing NOAEL from NOEL and LOAEL, and into classifying findings from toxicity test. Here, the three step method is newly suggested by applying the weight-based classification to the NOEL, NOAEL and LOAEL based on the findings.