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In Vitro-In Vivo Correlation (IVIVC) and Determining Drug Concentrations in Blood from Dissolution Testing – A Simple and Practical Approach

机译:体外体内相关性(IVIVC)和通过溶出度测试确定血液中的药物浓度-一种简单实用的方法

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摘要

Evaluating an IVIVC is a desirable feature for any drug dissolution test to establish relevance and confidence inassessing the quality and safety of solid oral dosage products, such as tablets and capsules. However, success in this areahas been limited. One of the reasons for this lack of success may be that the approaches described in the literature toachieve IVIVC appear to be intuitive expectations rather than an objective end-point based on scientific rationale. For example,rather than predicting an in vivo response based on in vitro results, which is the objective of IVIVC, attempts areusually made to match in vitro results with in vivo results by adjusting experimental conditions for in vitro testing. This articleprovides a discussion and clarification on the underlying scientific principles to help in alleviating current difficultiesin developing IVIVC. Further, it provides a simpler and practical approach based on experimental studies to achieve appropriateIVIVC by predicting blood drug levels from dissolution results.
机译:对于任何药物溶出度测试而言,评估IVIVC都是理想的功能,以建立相关性和信心来评估固体口服剂型产品(如片剂和胶囊剂)的质量和安全性。但是,在这一领域的成功受到限制。缺乏成功的原因之一可能是,文献中描述的实现IVIVC的方法似乎是直观的期望,而不是基于科学原理的客观终点。例如,不是基于作为IVIVC的目标的体外结果来预测体内应答,而是通常尝试通过调整用于体外测试的实验条件来使体外结果与体内结果相匹配。本文提供了有关基础科学原理的讨论和澄清,以帮助减轻当前开发IVIVC时遇到的困难。此外,它基于实验研究提供了一种更简单实用的方法,通过根据溶出度结果预测血液中的药物水平来实现适当的IVIVC。

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