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

作　　者：闫莉萍[1] 王海学[1] 彭健[1] 

机构地区：[1]国家食品药品监督管理局药品审评中心,北京100038

出　　处：《药物评价研究》2010年第5期332-334,共3页Drug Evaluation Research

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。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.

关 键 词：微球制剂 临床前 药理毒理 

分 类 号：R944.9[医药卫生—药剂学] R96[医药卫生—药学]