Translational pharmacokinetic-pharmacodynamic analysis in the pharmaceutical industry: an IQ Consortium PK-PD Discussion Group perspective

被引：15

作者：

Wong, Harvey ^{[1
,16
]}

Bohnert, Tonika ^{[2
]}

Damian-Lordache, Valeriu ^{[3
]}

Gibson, Christopher ^{[4
]}

Hsu, Cheng-Pang ^{[5
]}

Krishnatry, Anu Shilpa ^{[3
]}

Liederer, Bianca M. ^{[1
]}

Lin, Jing ^{[6
]}

Lu, Qiang ^{[7
]}

Mettetal, Jerome T. ^{[8
]}

Mudra, Daniel R. ^{[9
]}

Nijsen, Marjoleen J. M. A. ^{[10
]}

Schroeder, Patricia ^{[2
]}

Schuck, Edgar ^{[11
]}

Suryawanshi, Satyendra ^{[12
]}

Trapa, Patrick ^{[13
]}

Tsai, Alice ^{[14
]}

Wang, Haiqing ^{[12
]}

Wus, Fan ^{[15
]}

机构：

[1] Genentech Inc, San Francisco, CA 94080 USA

[2] Biogen Idec Inc, Cambridge, MA USA

[3] GlaxoSmithKline, Upper Merion, PA USA

[4] Merck Res Labs, PPDM, West Point, PA USA

[5] Amgen Inc, PKDM, Thousand Oaks, CA 91320 USA

[6] Sunovion, Marlborough, MA USA

[7] Sanofi, Bridgewater, NJ USA

[8] Astra Zeneca, Drug Safety & Metab, Waltham, MA USA

[9] Eli Lilly & Co, Indianapolis, IN 46285 USA

[10] Abbvie, N Chicago, IL USA

[11] Eisai Inc, Woodcliff Lake, NJ USA

[12] Bristol Myers Squibb, Princeton, NJ USA

[13] Pfizer Inc, Cambridge, MA USA

[14] Vertex Pharmaceut Inc, Boston, MA USA

[15] Novartis Inst Biomed Res, Cambridge, MA USA

[16] Univ British Columbia, Fac Pharmaceut Sci, Vancouver, BC, Canada

来源：

DRUG DISCOVERY TODAY | 2017年 / 22卷 / 10期

关键词：

TUMOR-GROWTH; PHARMACOKINETIC/PHARMACODYNAMIC MODEL; COMBINATION THERAPY; APOPTOSIS PROTEINS; DRUG DISCOVERY; CARDIAC-OUTPUT; PK/PD MODEL; INHIBITOR; SIMULATION; PHARMACOLOGY;

D O I：

10.1016/j.drudis.2017.04.015

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

With inadequate efficacy being the primary cause for the attrition of drug candidates in clinical development, the need to better predict clinical efficacy earlier in the drug development process has increased in importance in the pharmaceutical industry. Here, we review current applications of translational pharmacokinetic-pharmacodynamic (PK-PD) modeling of preclinical data in the pharmaceutical industry, including best practices. Preclinical translational PK-PD modeling has been used in many therapeutic areas and has been impactful to drug development. The role of preclinical translational PK-PD modeling in drug discovery and development will continue to evolve and broaden, given that its broad implementation in the pharmaceutical industry is relatively recent and many opportunities still exist for its further application.

引用

页码：1447 / 1459

页数：13

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