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浅析紫杉醇新剂型开发需关注的问题 被引量:1

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摘要 目的为促进和提高紫杉醇新剂型的开发效率,从注册审评角度提出研发建议。方法调研国外成功上市产品的研究思路并总结分析我国紫杉醇改剂型注册申请中常见的问题。结果与结论提出了紫杉醇改剂型研究的整体研究思路,并对于处方工艺筛选、质量研究、稳定性研究、药理毒理和临床研究中需重点关注的问题进行了分析,提出了合理建议。
作者 张宁 陈晓媛
出处 《中国药学杂志》 CAS CSCD 北大核心 2010年第22期1778-1780,共3页 Chinese Pharmaceutical Journal
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同被引文献8

  • 1D.OMalley,P.Gary,R.Salani,et al.Ohio state university,columbus,oh a phase II evaluation of carboplatin/paclitaxel/bevacizumab in the treatment of advanced-stage endometrial carcinoma:report of toxicity[J].Gynecol Oncolo,2011,120(S1):S33.
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  • 6Anna M.Feldweg,Chyh-Woei Lee,Ursula A.Matulonis,et al.Rapid desensitization for Hypersensitivity reactions to paclitaxel and docetaxel:a new standard protocol used in 77 successful treatments[J].Gynecolog Oncol,2005,96(3):824-829.
  • 7赵荆,于世英.紫杉醇白蛋白微粒治疗晚期乳腺癌临床观察[J].肿瘤防治研究,2008,35(11):815-818. 被引量:3
  • 8周琴,虞燕霞,季林山,尚尔宁.1例胰岛素过敏患者行脱敏疗法的药学监护[J].中国医院药学杂志,2010,30(17):1498-1499. 被引量:3

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