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

[21] COMBINED PHARMACOKINETIC-PHARMACODYNAMIC (PK-PD) MODEL TO PREDICT METHEMOGLOBIN FORMATION BY A NEW CANDIDATE ANTIMALARIAL
BRUECKNER, RP
FLECKENSTEIN, L
CLINICAL PHARMACOLOGY & THERAPEUTICS, 1990, 47 (02) : 156 - 156
[22] Pharmacokinetic-pharmacodynamic (PK-PD) modeling of cardiovascular effects of metoprolol in spontaneously hypertensive rats: a microdialysis study
Christian Höcht
Carla Di Verniero
Javier A. W. Opezzo
Guillermo F. Bramuglia
Carlos A. Taira
Naunyn-Schmiedeberg's Archives of Pharmacology, 2006, 373 : 310 - 318
[23] Mechanism-based pharmacokinetic-pharmacodynamic (PK-PD) modeling and simulation of oxaliplatin for hematological toxicity in rats
Kobuchi, Shinji
Katsuyama, Yosuke
Ito, Yukako
XENOBIOTICA, 2020, 50 (02) : 146 - 153
[24] Pharmacokinetic-pharmacodynamic (PK-PD) modeling of cardiovascular effects of metoprolol in spontaneously hypertensive rats:: a microdialysis study
Hocht, Christian
Di Verniero, Carla
Opezzo, Javier A. W.
Bramuglia, Guillermo F.
Taira, Carlos A.
NAUNYN-SCHMIEDEBERGS ARCHIVES OF PHARMACOLOGY, 2006, 373 (04) : 310 - 318
[25] Pharmacokinetic-Pharmacodynamic (PK-PD) Modeling of Tolvaptan and Diuretic Use on Fluid and Electrolyte Balance in Healthy Subjects
Van Wart, Scott
Shoaf, Susan
Mallikaarjun, Suresh
Mager, Donald
JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS, 2015, 42 : S43 - S44
[26] Pharmacokinetic-pharmacodynamic (Pk-Pd) modeling of entecavir: Prediction of log decrease in hepatitis B viral load
Fiske, W
Olsen, S
Yan, JH
Grasela, D
Phillips, L
Owen, J
HEPATOLOGY, 2002, 36 (04) : 631A - 631A
[27] Bioavailability assessment of arginine-vasopressin (AVP) using pharmacokinetic-pharmacodynamic (PK-PD) modeling in the rat
Miyazaki, M
Sawada, S
Nishide, T
Iwanaga, K
Morimoto, K
Kakemi, M
BIOLOGICAL & PHARMACEUTICAL BULLETIN, 2000, 23 (01) : 87 - 96
[28] Pharmacokinetic-pharmacodynamic (PK-PD) modeling and the rational selection of dosage regimes for the prudent use of antimicrobial drugs
Papich, Mark G.
VETERINARY MICROBIOLOGY, 2014, 171 (3-4) : 480 - 486
[29] The in vivo study on antioxidant activity of wendan decoction in treating hyperlipidemia: a pharmacokinetic-pharmacodynamic (PK-PD) model
Xu, Nan
Ijaz, Muhammad
Shu, Yishuo
Wang, Peng
Ma, Lei
Wang, Ping
Ding, Hailing
Shahbaz, Muhammad
Shi, Haiyan
FRONTIERS IN PHARMACOLOGY, 2024, 15
[30] The dose regimen formulation of tilmicosin against Lawsonia intracellularis in pigs by pharmacokinetic-pharmacodynamic (PK-PD) model
Luo, Wanhe
Qin, Hua
Chen, Dongmei
Wu, Mengru
Meng, Kuiyu
Zhang, Aoxue
Pan, Yunahu
Qu, Wei
Xie, Shuyu
MICROBIAL PATHOGENESIS, 2020, 147

← 1 2 3 4 5 →