Main points and inspirations of guidance for bioequivalence studies of oral solid products in European and American countries
文献类型：期刊论文
| 作者 | Zhang Yifan ; Zhong Dafang
|
| 刊名 | Chinese Journal New Drugs
 |
| 出版日期 | 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 In the corresponding draft guidance of China Pharmacopoeia, international new criteria are adopted.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 |
| 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. |
入库方式： OAI收割
来源：上海药物研究所
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