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用于多释放药物递送系统的非线性混合效应体内-体外相关性模型。

A nonlinear mixed effects IVIVC model for multi-release drug delivery systems.

作者信息

Rossenu S, Gaynor C, Vermeulen A, Cleton A, Dunne A

机构信息

Johnson and Johnson Pharmaceutical Research & Development, A Division of Janssen Pharmaceutica NV, Beerse, Belgium.

出版信息

J Pharmacokinet Pharmacodyn. 2008 Aug;35(4):423-41. doi: 10.1007/s10928-008-9095-3. Epub 2008 Sep 9.

Abstract

The purpose of this analysis was the development of an IVIVC model, which involves a convolution step as described by O'Hara et al. and to describe a dual-release system: a controlled release formulation, which contains an initial immediate release element. Four formulations of Galantamine were used to test this modelling technique and a level A IVIVC, which meets the FDA criteria for internal and external validation, was successfully developed.

摘要

该分析的目的是开发一个体内-体外相关性(IVIVC)模型,该模型涉及O'Hara等人描述的卷积步骤,并描述一种双释放系统:一种控释制剂,其中包含初始速释成分。使用四种加兰他敏制剂来测试这种建模技术,并成功开发出符合美国食品药品监督管理局(FDA)体内和体外验证标准的A级IVIVC模型。

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