Why has model-informed precision dosing not yet become common clinical reality? lessons from the past and a roadmap for the future

被引：171

作者：

Darwich, A. S. ^{[1
]}

Ogungbenro, K. ^{[1
]}

Vinks, A. A. ^{[2
,3
]}

Powell, J. R. ^{[4
]}

Reny, J-L ^{[5
,6
]}

Marsousi, N. ^{[7
]}

Daali, Y. ^{[5
,7
]}

Fairman, D. ^{[8
]}

Cook, J. ^{[9
]}

Lesko, L. J. ^{[10
]}

McCune, J. S. ^{[11
,12
]}

Knibbe, C. A. J. ^{[13
,14
]}

de Wildt, S. N. ^{[15
,16
,17
]}

Leeder, J. S. ^{[18
,19
]}

Neely, M. ^{[20
,21
]}

Zuppa, A. F. ^{[22
]}

Vicini, P. ^{[23
]}

Aarons, L. ^{[1
]}

Johnson, T. N. ^{[24
]}

Boiani, J. ^{[25
]}

Rostami-Hodjegan, A. ^{[1
,25
]}

机构：

[1] Univ Manchester, Div Pharm & Optometry, Ctr Appl Pharmacokinet Res, Manchester, Lancs, England

[2] Cincinnati Childrens Hosp Med Ctr, Cincinnati, OH 45229 USA

[3] Univ Cincinnati, Sch Med, Dept Pediat, Cincinnati, OH USA

[4] Univ N Carolina, Eshelman Sch Pharm, Chapel Hill, NC USA

[5] Univ Geneva, Sch Med, Geneva Platelet Grp, Geneva, Switzerland

[6] Geneva Univ Hosp, Dept Internal Med Rehabil & Geriatr, Geneva, Switzerland

[7] Geneva Univ Hosp, Clin Pharmacol & Toxicol, Geneva, Switzerland

[8] GSK Stevenage, Clin Pharmacol Modeling & Simulat, Stevenage, Herts, England

[9] Pfizer Inc, Clin Pharmacol, Groton, CT 06340 USA

[10] Univ Florida Lake Nona Orlando, Dept Pharmaceut, Ctr Pharmacometr & Syst Pharmacol, Orlando, FL USA

[11] Univ Washington, Dept Pharmaceut, Seattle, WA 98195 USA

[12] Fred Hitchinson Canc Res Ctr, Div Clin Res, Seattle, WA USA

[13] St Antonius Hosp, Dept Clin Pharm, Nieuwegein, Netherlands

[14] Leiden Univ, Leiden Acad Ctr Drug Res, Div Pharmacol, Leiden, Netherlands

[15] Radboud Univ Nijmegen, Dept Pharmacol & Toxicol, Nijmegen, Netherlands

[16] Erasmus MC Sophia Childrens Hosp, Intens Care, Rotterdam, Netherlands

[17] Erasmus MC Sophia Childrens Hosp, Dept Pediat Surg, Rotterdam, Netherlands

[18] Childrens Mercy Hosp & Clin, Div Pediat Pharmacol & Med Toxicol, Dept Pediat, Kansas City, MO USA

[19] Univ Missouri, Dept Pharmacol, Kansas City, MO 64110 USA

[20] Univ Southern Calif, Los Angeles, CA USA

[21] Childrens Hosp Los Angeles, Los Angeles, CA 90027 USA

[22] Childrens Hosp Philadelphia, Philadelphia, PA 19104 USA

[23] MedImmune, Clin Pharmacol Pharmacometr & DMPK, Cambridge, England

[24] Certara, Blades Enterprise Ctr, Sheffield, S Yorkshire, England

[25] Epstein Becker & Green, Washington, DC 20037 USA

来源：

CLINICAL PHARMACOLOGY & THERAPEUTICS | 2017年 / 101卷 / 05期

关键词：

PHARMACOKINETIC MODEL; MORBIDLY OBESE; CHILDREN; INFANTS; PBPK; VANCOMYCIN; MORPHINE; PRETERM; DOSAGE; TRIAL;

D O I：

10.1002/cpt.659

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Patient groups prone to polypharmacy and special subpopulations are susceptible to suboptimal treatment. Refined dosing in special populations is imperative to improve therapeutic response and/or lowering the risk of toxicity. Model-informed precision dosing (MIPD) may improve treatment outcomes by achieving the optimal dose for an individual patient. There is, however, relatively little published evidence of large-scale utility and impact of MIPD, where it is often implemented as local collaborative efforts between academia and healthcare. This article highlights some successful applications of bringing MIPD to clinical care and proposes strategies for wider integration in healthcare. Considerations are brought up herein that will need addressing to see MIPD become widespread clinical practice, among those, wider interdisciplinary collaborations and the necessity for further evidence-based efficacy and cost-benefit analysis of MIPD in healthcare. The implications of MIPD on regulatory policies and pharmaceutical development are also discussed as part of the roadmap.

引用

页码：646 / 656

页数：11

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