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Temozolomide capsule is a first-line chemotherapeutic agent for the treatment of glioblastoma and anaplastic astrocytoma. Combined with radiotherapy, it can significantly improve the survival rate of patients, which is of high clinical value. Based on the public information on the websites of National Medical Products Administration, Food and Drug Administration, European Medicines Angecy and Pharmaceuticals and Medical Devices Angecy, the contents of Chineses Pharmacopoeia, United States Pharmacopeia, British Pharmacopeia, and the requirements of The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and domestic chemical generic drugs related guidelines, this paper proposed the pharmaceutical research and development concerns of this product, so as to promote the marketing of generic drugs.

, authors=Xin-zhu NA, Yan HE, Jun-lin ZHANG, Xiao-fei SI, authorsList=Xin-zhu NA, Yan HE, Jun-lin ZHANG, Xiao-fei SI, authorCompany=null, correspAuthors=Yan HE, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1291339159512282020, articleId=1291339158543397794, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=替莫唑胺胶囊仿制药药学研发探讨, columnId=1291339025730760957, journalTitle=中国临床药理学杂志, columnName=药物评价与管理, runingTitle=null, highlight=null, articleAbstract=

替莫唑胺胶囊是治疗胶质母细胞瘤和间变性星形细胞瘤的一线化疗药物，联合放疗可显著提高患者生存率，具有较高的临床价值。本文根据国家药品监督管理局、美国食品药品监督管理局、欧洲药品管理局和日本药品医疗器械管理局官方网站公开信息，中国药典、美国药典、英国药典的收载内容，并结合药品注册技术协调会及国内化学仿制药相关指导原则要求，提出该产品的药学研发关注点，以促进仿制药的上市。

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那馨竹（1989-），女，硕士研究生，助理研究员，主要从事化学仿制药审评方面的工作

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那馨竹（1989-），女，硕士研究生，助理研究员，主要从事化学仿制药审评方面的工作

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