作者
Mohd Yasir, Mohd Asif, Iti Chauhan, Alok Pratap Singh
发表日期
2010/6/1
来源
Drug Invention Today
卷号
2
期号
6
简介
Correlation between in vitro and in vivo data have long been sought in biopharmaceutical as a mean of modeling the human organism and thereby monitor and optimize the dosage form with the fewest possible trial in man. One of the challenge of biopharmaceutics research is correlating in vitrodrug release (dissolution) information of various types of drug formulations to the in vivo drug profile and to provide a regulatory perspective on its utility in product development and optimization. A successful correlation can assist in selection of appropriate dissolution acceptance and can be used as a surrogate for in vivo bioavailability and to support biowaivers. It can also assist in quality control for certain scale-up and post approval changes (SUPAC). With the proliferation of modified-release products, it becomes necessary to examine the concept of In vitro-In vivoCorrelation (IVIVC) in greater depth. Investigations of IVIVC are increasingly becoming an integral part of extended release drug development. In addition, the Biopharmaceutical Classification System provides a science-based guidance on solubility and permeability drug issues, which are indicators of predictive IVIVC. The aim of this review article is to represents the various notions of IVIVC and its applications, Biopharmaceutical classification systems (BCS) & application of BCS in IVIVC development, Various type of dissolution media and their importance and methodology of dissolution have been highlighted.
引用总数
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学术搜索中的文章
M Yasir, M Asif, I Chauhan, AP Singh - Drug Invention Today, 2010