In vitro-In Vivo Correlations: Tricks and Traps

被引：84
作者：
Cardot, J. -M. [1 ]
Davit, B. M. [2 ]
机构：
[1] Auvergne Univ, UFR Pharm, ERT CIDAM, Dept Biopharmaceut, F-63001 Clermont Ferrand, France
[2] US FDA, Div Bioequivalence 2, Off Gener Drugs, Ctr Drug Evaluat & Res, Rockville, MD 20857 USA
来源：
AAPS JOURNAL | 2012年 / 14卷 / 03期
关键词：
biowaiver; in vitro-in vivo correlation (IVIVC); predictability; prediction; time scaling; ORAL-DRUG ABSORPTION; IVIVC; LEVEL; MODEL; DISSOLUTION; FORMULATION; SYSTEM;
D O I：
10.1208/s12248-012-9359-0
中图分类号：
R9 [药学];
学科分类号：
1007 ;
摘要：
In vitro-in vivo correlation (IVIVC) is a biopharmaceutical tool recommended to be used in development of formulation. When validated, it can speed up development of formulation, be used to fix dissolution limits and also as surrogate of in vivo study. However, as do all tools, it presents limitations and traps. The aim of the present paper is to investigate five common traps which could limit either the setting or use of IVIVC (1) using mean or individual values; (2) correction of absolute bioavailability; (3) correction of lag time and time scaling; (4) flip-flop model; and (5) predictability corrections.
引用
收藏
页码：491 / 499
页数：9
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