A New Way in Deciding NOAEL Based on the Findings from GLP-Toxicity Test

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Park, Yeong-Chul;Cho, Myung-Haing

  • 투고 : 2011.07.02
  • 심사 : 2011.08.11
  • 발행 : 2011.09.01

초록

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.

키워드

GLP;NOAEL;Adverse effects;Weight-based classification;Non-carcinogenic test

참고문헌

  1. Lewis, R.W., Billington, R., Debryune, E., Gamer, A., Lang, B. and Carpanini, F. (2002). Recognition of adverse and nonadverse effects in toxicity studies. Toxicol. Pathol., 30, 66-74. https://doi.org/10.1080/01926230252824725
  2. Ness, D. (2006). Writing the nonclinical study final report: A focus on compliance, accuracy, and scientific soundness. 2006 issue of APO, 7, 36-41.
  3. US FDA. (2005). Guidance for Industry Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers. Pharmacology and Toxicology.
  4. US National Academy of Sciences. (1975). Principles for Evaluating Chemicals in the Environment-. A Report of the Committee for the Working Conference on Principles of Protocols for Evaluating Chemicals in the Environment. National Academy of Sciences, National Research Council, Washington, DC.

피인용 문헌

  1. 1. QSAR as a random event: a case of NOAEL vol.22, pp.11, 2015, doi:10.5487/TR.2011.27.3.133
  2. 2. Repeated Dose 90-Day Oral Toxicity Study of Dried Thermitomyces albuminosus Powder in Rats vol.26, pp.10, 2016, doi:10.5487/TR.2011.27.3.133
  3. 3. Toward a unifying strategy for the structure-based prediction of toxicological endpoints vol.90, pp.10, 2016, doi:10.5487/TR.2011.27.3.133