Physiologically based pharmacokinetic modeling as a tool for drug development

被引:49
作者
Charnick, SB
Kawai, R
Nedelman, JR
Lemaire, M
Niederberger, W
Sato, H
机构
[1] SANDOZ PHARMACEUT LTD, TSUKUBA RES INST, IBARAKI, OSAKA 30033, JAPAN
[2] SANDOZ PHARMACEUT LTD, DRUG SAFETY, CH-4002 BASEL, SWITZERLAND
来源
JOURNAL OF PHARMACOKINETICS AND BIOPHARMACEUTICS | 1995年 / 23卷 / 02期
关键词
physiologically based pharmacokinetics; modeling; drug development;
D O I
10.1007/BF02354273
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
Since the pioneering work of Haggard and Teorell in the first half of the 20th century, and of Bischoff and Dedrick in the late 1960s, physiologically based pharmacokinetic (PBPK) modeling has gone through cycles of general acceptance, and of healthy skepticism. Recently, however, the trend in the pharmaceuticals industry has been away from PBPK models. This is understandable when one considers the time and effort necessary to develop, test, and implement a typical PBPK model, and the fact that in the present-day environment for drug development, efficacy and safety must be demonstrated and drugs brought to market more rapidly. Although there are many modeling tools available to the pharmacokineticist today, many of which are preferable to PBPK modeling in most circumstances, there ar several situations in which PBPK modeling provides distinct benefits that outweigh the drawbacks of increased time and effort for implementation. IN this Commentary, we draw on our experience with this modeling technique in an industry setting to provide guidelines on when PBPK modeling techniques could be applied in an industrial setting to satisfy the needs of regulatory customers. We hope these guidelines will assist researcher in deciding when to apply PBPK modeling techniques. It is our contention that PBPK modeling should be viewed as one of many modeling tools for drug development.
引用
收藏
页码:217 / 229
页数:13
相关论文
共 71 条
[21]   SIMULTANEOUS ADMINISTRATION OF MULTIPLE MODEL SUBSTRATES TO ASSESS HEPATIC DRUG CLEARANCE [J].
CROM, WR ;
WEBSTER, SL ;
BOBO, L ;
TERESI, ME ;
RELLING, MV ;
EVANS, WE .
CLINICAL PHARMACOLOGY & THERAPEUTICS, 1987, 41 (06) :645-650
[22]  
DROZ PO, 1989, BRIT J IND MED, V46, P447
[23]   PHYSIOLOGICAL PHARMACOKINETIC MODELS - SOME ASPECTS OF THEORY, PRACTICE AND POTENTIAL [J].
DSOUZA, RW ;
BOXENBAUM, H .
TOXICOLOGY AND INDUSTRIAL HEALTH, 1988, 4 (02) :151-171
[24]   A MULTIORGAN, AXIALLY DISTRIBUTED MODEL OF CAPILLARY-PERMEABILITY FOR A MAGNETIC-RESONANCE-IMAGING CONTRAST AGENT [J].
EATON, SM ;
WEDEKING, P ;
TWEEDLE, MF ;
ECKELMAN, WC .
JOURNAL OF PHARMACEUTICAL SCIENCES, 1993, 82 (05) :531-536
[25]   PHYSIOLOGICAL PHARMACOKINETIC MODEL OF ADRIAMYCIN DELIVERED VIA MAGNETIC ALBUMIN MICROSPHERES IN THE RAT [J].
GALLO, JM ;
HUNG, CT ;
GUPTA, PK ;
PERRIER, DG .
JOURNAL OF PHARMACOKINETICS AND BIOPHARMACEUTICS, 1989, 17 (03) :305-326
[26]   PHYSIOLOGICALLY BASED PHARMACOKINETIC AND PHARMACODYNAMIC MODEL FOR THE INHIBITION OF ACETYLCHOLINESTERASE BY DIISOPROPYLFLUOROPHOSPHATE [J].
GEARHART, JM ;
JEPSON, GW ;
CLEWELL, HJ ;
ANDERSEN, ME ;
CONOLLY, RB .
TOXICOLOGY AND APPLIED PHARMACOLOGY, 1990, 106 (02) :295-310
[27]   PHYSIOLOGICALLY BASED PHARMACOKINETIC MODELING - PRINCIPLES AND APPLICATIONS [J].
GERLOWSKI, LE ;
JAIN, RK .
JOURNAL OF PHARMACEUTICAL SCIENCES, 1983, 72 (10) :1103-1127
[28]  
GIFFORD E, 1991, J COMP AID MOL DIS, V5
[29]  
Gilbaldi M, 1982, PHARMACOKINETICS
[30]  
Haggard HW, 1924, J BIOL CHEM, V59, P753