Linear correlation of the fraction of oral dose absorbed of 64 drugs between humans and rats

被引:218
作者
Chiou, WL [1 ]
Barve, A [1 ]
机构
[1] Univ Illinois, Coll Pharm, Dept Pharmaceut & Pharmacodynam MC865, Chicago, IL 60612 USA
关键词
oral absorption; rats; humans; inter-species;
D O I
10.1023/A:1011981317451
中图分类号
O6 [化学];
学科分类号
0703 ;
摘要
The preliminary work was presented at the meeting of the Expert Panel on Biopharmaceutics Drug Classification System of the Food and Drug Administration on October 21, 1997 at Food and Drug Administration in Rockville, Maryland. The content of this paper was also presented under the title, 'Drug absorption studies in vivo in rats for predicting fraction of drug absorbed in humans' at the AAPS Workshop on Permeability Definitions and Regulatory Standards for Bioequivalance, August 17-19, 1998, Arlington, Virginia.
引用
收藏
页码:1792 / 1795
页数:4
相关论文
共 18 条
[1]   A THEORETICAL BASIS FOR A BIOPHARMACEUTIC DRUG CLASSIFICATION - THE CORRELATION OF IN-VITRO DRUG PRODUCT DISSOLUTION AND IN-VIVO BIOAVAILABILITY [J].
AMIDON, GL ;
LENNERNAS, H ;
SHAH, VP ;
CRISON, JR .
PHARMACEUTICAL RESEARCH, 1995, 12 (03) :413-420
[2]   Intestinal drug absorption and metabolism in cell cultures: Caco-2 and beyond [J].
Artursson, P ;
Borchardt, RT .
PHARMACEUTICAL RESEARCH, 1997, 14 (12) :1655-1658
[3]   CORRELATION BETWEEN ORAL-DRUG ABSORPTION IN HUMANS AND APPARENT DRUG PERMEABILITY COEFFICIENTS IN HUMAN INTESTINAL EPITHELIAL (CACO-2) CELLS [J].
ARTURSSON, P ;
KARLSSON, J .
BIOCHEMICAL AND BIOPHYSICAL RESEARCH COMMUNICATIONS, 1991, 175 (03) :880-885
[4]   Caco-2 monolayers in experimental and theoretical predictions of drug transport [J].
Artursson, P ;
Palm, K ;
Luthman, K .
ADVANCED DRUG DELIVERY REVIEWS, 1996, 22 (1-2) :67-84
[5]   New perspectives on the theory of permeability and resistance in the study of drug transport and absorption [J].
Chiou, WL .
JOURNAL OF PHARMACOKINETICS AND BIOPHARMACEUTICS, 1996, 24 (04) :433-442
[6]   We may not measure the correct intestinal wall permeability coefficient of drugs: Alternative absorptive clearance concept [J].
Chiou, WL .
JOURNAL OF PHARMACOKINETICS AND BIOPHARMACEUTICS, 1995, 23 (03) :323-331
[7]  
CHIOU WL, 1994, INT J CLIN PHARM TH, V32, P474
[8]   THE VALIDATION OF THE INTESTINAL PERMEABILITY APPROACH TO PREDICT ORAL FRACTION OF DOSE ABSORBED IN HUMANS AND RATS [J].
CHIOU, WL .
BIOPHARMACEUTICS & DRUG DISPOSITION, 1995, 16 (01) :71-75
[9]   In vitro permeability through Caco-2 cells is not quantitatively predictive of in vivo absorption for peptide-like drugs absorbed via the dipeptide transporter system [J].
Chong, SH ;
Dando, SA ;
Soucek, KM ;
Morrison, RA .
PHARMACEUTICAL RESEARCH, 1996, 13 (01) :120-123
[10]   Improved prediction of in vivo peroral absorption from in vitro intestinal permeability using an internal standard to control for intra- and inter-rat variability [J].
Dowty, ME ;
Dietsch, CR .
PHARMACEUTICAL RESEARCH, 1997, 14 (12) :1792-1796