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

共 50 条

[1] HYDROMORPHONE BIOAVAILABILITY AND PHARMACOKINETIC-PHARMACODYNAMIC (PK-PD) RELATIONSHIPS
INTURRISI, C
PORTENOY, R
STILLMAN, M
COLBURN, W
FOLEY, K
CLINICAL PHARMACOLOGY & THERAPEUTICS, 1988, 43 (02) : 162 - 162
[2] METHADONE INFUSIONS - PHARMACOKINETIC-PHARMACODYNAMIC (PK-PD) RELATIONSHIPS
INTURRISI, C
PORTENOY, R
MAX, M
COLBURN, W
FOLEY, K
CLINICAL PHARMACOLOGY & THERAPEUTICS, 1987, 41 (02) : 211 - 211
[3] Mechanism-based pharmacokinetic-pharmacodynamic (PK-PD) modeling in translational drug research
Danhof, Meindert
de Lange, Elizabeth C. M.
Della Pasqua, Oscar E.
Ploeger, Bart A.
Voskuyl, Rob A.
TRENDS IN PHARMACOLOGICAL SCIENCES, 2008, 29 (04) : 186 - 191
[4] A microfluidic device for a pharmacokinetic-pharmacodynamic (PK-PD) model on a chip
Sung, Jong Hwan
Kam, Carrie
Shuler, Michael L.
LAB ON A CHIP, 2010, 10 (04) : 446 - 455
[5] The role of mechanism-based pharmacokinetic-pharmacodynamic (PK-PD) modelling in translational research of biologics
Agoram, Balaji M.
Martin, Steven W.
van der Graaf, Piet H.
DRUG DISCOVERY TODAY, 2007, 12 (23-24) : 1018 - 1024
[6] PHARMACOKINETIC-PHARMACODYNAMIC (PK-PD) MODELING OF MIDAZOLAM-FLUMAZENIL INTERACTIONS
FISET, P
EGAN, T
LEMMENS, H
SHAFER, S
STANSKI, D
ANESTHESIOLOGY, 1993, 79 (3A) : A362 - A362
[7] How pharmacokinetic-pharmacodynamic (PK-PD) parameters influence antibiotic use
Mazzei, T.
JOURNAL OF CHEMOTHERAPY, 2006, 18 : 19 - 21
[8] Pharmacokinetic-Pharmacodynamic (PK-PD) Model for Tolvaptan in Patients with Hypervolemic Hyponatremia
Van Wart, Scott
Shoaf, Susan
Mallikaarjun, Suresh
Mager, Donald
JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS, 2015, 42 : S76 - S76
[9] PHARMACOKINETIC-PHARMACODYNAMIC (PK-PD) MODELING FOR METFORMIN IN HEALTHY VOLUNTEERS.
Kim, Y.
Cho, S.
Lee, D.
Son, H.
Roh, H.
Son, M.
Heo, Y.
Park, K.
CLINICAL PHARMACOLOGY & THERAPEUTICS, 2014, 95 : S48 - S48
[10] A Microfluidic Perfusion Platform for In Vitro Analysis of Drug Pharmacokinetic-Pharmacodynamic (PK-PD) Relationships
Yadir A. Guerrero
Diti Desai
Connor Sullivan
Erick Kindt
Mary E. Spilker
Tristan S. Maurer
Deepak E. Solomon
Derek W. Bartlett
The AAPS Journal, 22

← 1 2 3 4 5 →