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| 化学药物口服缓控释制剂体内外相关性研究 | |
| 引用本文： | 高杨,黄钦,马玉楠. 化学药物口服缓控释制剂体内外相关性研究[J]. 中国新药杂志, 2010, 0(10) |
| 作者姓名： | 高杨 黄钦 马玉楠 |
| 作者单位： | 国家食品药品监督管理局药品审评中心; |
| 摘 要： | 《口服缓控释制剂药学研究技术指导原则》中多处提到了体内外相关性,文中试图通过对体内外相关性(IVIVC)的定义、创建、评价和应用等方面的介绍,对IVIVC可行性的评估以及IVIVC与生物豁免和释放度质量标准的关系的讨论,帮助研发者理解该指导原则的相关内容。 |
| 关 键 词： | 缓控释 体内外相关 生物豁免 释放度 |
In-vivo in-vitro correlation of extended release oral dosage forms |
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| GAO Yang,HUANG Qin,MA Yu-nan. In-vivo in-vitro correlation of extended release oral dosage forms[J]. Chinese Journal of New Drugs, 2010, 0(10) | |
| Authors: | GAO Yang HUANG Qin MA Yu-nan |
| Affiliation: | GAO Yang,HUANG Qin,MA Yu-nan(Center for Drug Evaluation,State Food , Drug Administration,Beijing 100038,China) |
| Abstract: | Guidance for Pharmaceutical Researches on Extended Release Oral Dosage Forms refers to the expression In-vivo in-vitro correlation(IVIVC) in several lines with few explanations.This article intends to assist applicants have a better understanding on the guidance by introducing the concepts,developments,evaluations,and applications of IVIVC,the feasibility of IVIVC and the role of IVIVC in bio-waiver and dissolution specification. |
| Keywords: | extended release in-vivo in-vitro correlation bio-waiver dissolution |
| 本文献已被 CNKI 等数据库收录！ | |