The Future Is Now: Model-Based Clinical Trial Design for Alzheimer's Disease

被引：51

作者：

Romero, K. ^{[1
]}

Ito, K. ^{[2
]}

Rogers, J. A. ^{[3
]}

Polhamus, D. ^{[3
]}

Qiu, R. ^{[2
]}

Stephenson, D. ^{[1
]}

Mohs, R. ^{[4
]}

Lalonde, R. ^{[2
]}

Sinha, V. ^{[5
]}

Wang, Y. ^{[5
]}

Brown, D. ^{[6
]}

Isaac, M. ^{[6
]}

Vamvakas, S. ^{[6
]}

Hemmings, R. ^{[6
]}

Pani, L. ^{[6
]}

Bain, L. J. ^{[1
]}

Corrigan, B. ^{[2
]}

机构：

[1] Crit Path Inst, Tucson, AZ 85718 USA

[2] Pfizer Inc, Groton, CT 06340 USA

[3] Metrum Res Grp, Tariffville, CT USA

[4] Eli Lilly, Lilly Corp Ctr, Indianapolis, IN USA

[5] US FDA, Silver Spring, MD USA

[6] European Med Agcy, London, England

来源：

CLINICAL PHARMACOLOGY & THERAPEUTICS | 2015年 / 97卷 / 03期

关键词：

D O I：

10.1002/cpt.16

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Failures in trials for Alzheimer's disease (AD) may be attributable to inadequate dosing, population selection, drug inefficacy, or insufficient design optimization. The Coalition Against Major Diseases (CAMD) was formed in 2008 to develop drug development tools (DDT) to expedite drug development for AD and Parkinson's disease.(1) CAMD led a process that successfully advanced a clinical trial simulation (CTS) tool for AD through the formal regulatory review process at the US Food and Drug Administration (FDA) and European Medicines Agency (EMA).

引用

页码：210 / 214

页数：5

共 7 条

[1]

Food and Drug Administration: draft guidance for industry, ALZH DIS DEV DRUGS T

[2] METHODOLOGIC ASPECTS OF A POPULATION PHARMACODYNAMIC MODEL FOR COGNITIVE EFFECTS IN ALZHEIMER PATIENTS TREATED WITH TACRINE [J].