闫莉萍,王海学,彭 健.微球制剂的临床前药理毒理研究和评价[J].药物评价研究,2010,33(5):332-334
微球制剂的临床前药理毒理研究和评价
Preclinical studies and evaluation on pharmaco-toxicology of microsphere products
投稿时间:2010-07-11  
DOI:10.7501/j.issn.0253-6376.[year].[issue].[sequence]
中文关键词:  微球制剂;临床前;药理毒理
英文关键词:microsphere products; preclinical study; pharmaco-toxicology
基金项目:
作者单位
闫莉萍,王海学,彭 健 国家食品药品监督管理局 药品审评中心,北京 100038 
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中文摘要:
      总结国内外批准上市和研发中微球剂型的药理毒理研究和评价情况。根据已上市微球制剂研发中所进行的药理毒理研究信息,总结微球制剂非临床药理毒理研究中需关注的研究内容和试验要求。希望微球制剂研究者能够根据微球制剂的开发目的和特点,开展完善合理的临床前药理毒理研究,以阐明开发微球制剂的药理毒理特点,将微球制剂开发成为临床需要且特点明显的新药。
英文摘要:
      Preclinical studies and evaluation on pharmaco-toxicology of microsphere products approved to the market both domestic and abroad were outlined. According to the pharmaco-toxicologic information on prenclinical studies of microsphere drugs in market, the research and experimental requirements were concerned. Adequate preclinical studies should be designed to clarify the potential clinical benefit and/or develop the new drugs with the characteristics of microsphere products.
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