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新药中遗传毒性杂质及其管理 被引量:6

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出处 《浙江预防医学》 2007年第12期65-66,68,共3页 Zhejiang Journal of Preventive Medicine
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  • 1R.Renwick A G, Cheeseman M, K, et al. Structure- based threshold of toxicology concern (TTC): guidance for application to substances present at low levels in the diet [J]. Food Chem Toxicol, 2004, 42: 65-83.
  • 2Robert M, M. Andino, D. DeGeorge, et al. Representing Establishment of allowable concentrations of genotoxic impurities in drug substance and product [J]. Winter Toxicology Forum, 2005, 1:5 - 8.
  • 3Kroes. RS, Kleiner J, Renwick A. The Threshold of Toxicologieal Concem Concept in Risk Assessment [ J ]. Toxicological Sciences, 2005, 86 (2): 226-230.
  • 4Renwick A. Toxicology databases and the concept of thresholds of toxicological concern as used by the JECFA for the safety evaluation of flavouringagents [J]. Toxicol Lett, 2004, 149: 223-234.
  • 5David K, David S. Setting Limits for Genotoxic Impurities in Drug Substances: Threshold- Baaed and Pragmatic Approsches[ J ]. Leading Art Int J Pham Med, 2004, 18 (4) : 197 - 207.
  • 6Dobo K L, Greene N, Cyr M O,et al,The application of structure - based assessment to support safety and chemistry diligence to manage genotoxic impurities in active pharmaceutical ingredients during drug development [ J]. Reg Tox Pharm, 2006. 44:282 - 293.

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