Main points and inspirations of guidance for bioequivalence studies of oral solid products in European and American countries

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	Main points and inspirations of guidance for bioequivalence studies of oral solid products in European and American countries
	Zhang Yifan; Zhong Dafang
刊名	Chinese Journal New Drugs
	2014
卷号	23 期号:13 页码:1501-1505
关键词	solid oral product bioequivalence study guidance reference product highly variable drug products
ISSN号	1003-3734
其他题名	欧美国家口服固体制剂生物等效性试验指导原则的要点和启示
文献子类	Article
英文摘要	Bioequivalence study is critical for evaluating the inherent quality of generic oral solid products. Guidelines have been issued by regulation agencies of European and American countries and revised based on applications and experiments. Their main points include the study design, selection of reference product, special requirements for highly variable or narrow therapeutic index drug products, etc., reflecting the latest developments. In the corresponding draft guidance of China Pharmacopoeia, international new criteria are adopted. The agreement evaluation of generic drug products in China will play an important role in promoting the bioequivalence of oral solid products.
WOS研究方向	Pharmacology & Pharmacy (provided by Clarivate Analytics)
语种	中文
CSCD记录号	CSCD:5184571
内容类型	期刊论文
源URL	[http://119.78.100.183/handle/2S10ELR8/269328]
专题	上海药物代谢研究中心
通讯作者	Zhang Yifan; Zhong Dafang
作者单位	Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai 201203, China.
推荐引用方式 GB/T 7714	Zhang Yifan,Zhong Dafang. Main points and inspirations of guidance for bioequivalence studies of oral solid products in European and American countries[J]. Chinese Journal New Drugs,2014,23(13):1501-1505.
APA	Zhang Yifan,&Zhong Dafang.(2014).Main points and inspirations of guidance for bioequivalence studies of oral solid products in European and American countries.Chinese Journal New Drugs,23(13),1501-1505.
MLA	Zhang Yifan,et al."Main points and inspirations of guidance for bioequivalence studies of oral solid products in European and American countries".Chinese Journal New Drugs 23.13(2014):1501-1505.