Physiologically Based Pharmacokinetic Modeling: From Regulatory Science to Regulatory Policy

被引：40

作者：

Sinha, V. ^{[1
]}

Zhao, P. ^{[1
]}

Huang, S. M. ^{[1
]}

Zineh, I. ^{[1
]}

机构：

[1] US FDA, Off Clin Pharmacol, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA

来源：

CLINICAL PHARMACOLOGY & THERAPEUTICS | 2014年 / 95卷 / 05期

关键词：

DRUG DEVELOPMENT;

D O I：

10.1038/clpt.2014.46

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Assessment of controllable sources of intra- and interpatient variability in drug response is of critical importance in the regulatory evaluation of new drugs.(1) Although determinants of response variability would ideally be understood and accounted for before approval of a new pharmaceutical product, this is rarely the case for all; clinical trials in specific populations that definitively test optimal dosing in patient management strategies are not routinely performed prior to drug approval.

引用

页码：478 / 480

页数：4

共 10 条

[1]

Conrado DJ, 2013, PHARMACOGENOMICS, V14, P215, DOI [10.2217/PGS.12.203, 10.2217/pgs.12.203]

[2] Transporters in Drug Development and Clinical Pharmacology [J].

Giacomini, K. M. ;

Huang, S-M .

CLINICAL PHARMACOLOGY & THERAPEUTICS, 2013, 94 (01) :3-9

[3] The Utility of Modeling and Simulation in Drug Development and Regulatory Review [J].

Huang, Shiew-Mei ;

Abernethy, Darrell R. ;

Wang, Yaning ;

Zhao, Ping ;

Zineh, Issam .

JOURNAL OF PHARMACEUTICAL SCIENCES, 2013, 102 (09) :2912-2923

[4] UNDERSTANDING CONSEQUENCES OF CONCURRENT THERAPIES [J].

PECK, CC ;

TEMPLE, R ;

COLLINS, JM .

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 1993, 269 (12) :1550-1552

[5] Physiologically Based Pharmacokinetics Joined With In Vitro-In Vivo Extrapolation of ADME: A Marriage Under the Arch of Systems Pharmacology [J].

Rostami-Hodjegan, A. .

CLINICAL PHARMACOLOGY & THERAPEUTICS, 2012, 92 (01) :50-61

[6] Physiologically-Based Pharmacokinetics in Drug Development and Regulatory Science [J].

Rowland, Malcolm ;

Peck, Carl ;

Tucker, Geoffrey .

ANNUAL REVIEW OF PHARMACOLOGY AND TOXICOLOGY, VOL 51, 2011, 2011, 51 :45-73

[7]

US Food and Drug Administration, 2012, PRESENTATION AT 2012

[8]

US Food and Drug Administration, 2010, ADVANCING REGULATORY

[9] PBPK Model Describes the Effects of Comedication and Genetic Polymorphism on Systemic Exposure of Drugs That Undergo Multiple Clearance Pathways [J].

Vieira, Md L. T. ;

Kim, M-J ;

Apparaju, S. ;

Sinha, V. ;

Zineh, I. ;

Huang, S-M ;

Zhao, P. .

CLINICAL PHARMACOLOGY & THERAPEUTICS, 2014, 95 (05) :550-557

[10] Applications of Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulation During Regulatory Review [J].

Zhao, P. ;

Zhang, L. ;

Grillo, J. A. ;

Liu, Q. ;

Bullock, J. M. ;

Moon, Y. J. ;

Song, P. ;

Brar, S. S. ;

Madabushi, R. ;

Wu, T. C. ;

Booth, B. P. ;

Rahman, N. A. ;

Reynolds, K. S. ;

Berglund, E. Gil ;

Lesko, L. J. ;

Huang, S-M .

CLINICAL PHARMACOLOGY & THERAPEUTICS, 2011, 89 (02) :259-267

← 1 →