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

被引：10

作者：

Rossenu, S. ^{[1
]}

Gaynor, C. ^{[2
]}

Vermeulen, A. ^{[1
]}

Cleton, A. ^{[3
]}

Dunne, A. ^{[2
]}

机构：

[1] Johnson & Johnson Pharmaceut Res & Dev, Div Janssen Pharmaceut NV, Beerse, Belgium

[2] Univ Coll Dublin, UCD Sch Math Sci, Dublin 4, Ireland

[3] Pfizer, Sandwich, Kent, England

来源：

JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS | 2008年 / 35卷 / 04期

关键词：

dissolution; in vitro/in vivo correlation; population pharmacokinetics; controlled release;

D O I：

10.1007/s10928-008-9095-3

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

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((R)) 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.

引用

页码：423 / 441

页数：19

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