Model-based drug development

被引:311
作者
Lalonde, R. L. [1 ]
Kowalski, K. G.
Hutmacher, M. M.
Ewy, W.
Nichols, D. J.
Milligan, P. A.
Corrigan, B. W.
Lockwood, P. A.
Marshall, S. A.
Benincosa, L. J.
Tensfeldt, T. G.
Parivar, K.
Amantea, M.
Glue, P.
Koide, H.
Miller, R.
机构
[1] Pfizer Inc, Global Res & Dev, Dept Clin Pharmacol, Groton, CT 06340 USA
[2] Pfizer Inc, Global Res & Dev, Dept Clin Pharmacol, Ann Arbor, MI USA
[3] Pfizer Inc, Global Res & Dev, Dept Clin Pharmacol, Sandwich, Kent, England
[4] Pfizer Inc, Global Res & Dev, Dept Clin Pharmacol, New York, NY USA
[5] Pfizer Inc, Global Res & Dev, Dept Clin Pharmacol, La Jolla, CA USA
[6] Pfizer Inc, Global Res & Dev, Dept Clin Pharmacol, Tokyo, Japan
[7] Pfizer Inc, Global Res & Dev, Dept Stat, Groton, CT 06340 USA
[8] Pfizer Inc, Global Res & Dev, Dept Stat, Ann Arbor, MI USA
[9] Pfizer Inc, Global Res & Dev, Dept Stat, Sandwich, Kent, England
[10] Pfizer Inc, Global Res & Dev, Dept Stat, New York, NY USA
[11] Pfizer Inc, Global Res & Dev, Dept Stat, La Jolla, CA USA
[12] Pfizer Inc, Global Res & Dev, Dept Stat, Tokyo, Japan
关键词
D O I
10.1038/sj.clpt.6100235
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
The low productivity and escalating costs of drug development have been well documented over the past several years. Less than 10% of new compounds that enter clinical trials ultimately make it to the market, and many more fail in the preclinical stages of development. These challenges in the "critical path" of drug development are discussed in a 2004 publication by the US Food and Drug Administration. The document emphasizes new tools and various opportunities to improve drug development. One of the opportunities recommended is the application of "model-based drug development (MBDD)." This paper discusses what constitutes the key elements of MBDD and how these elements should fit together to inform drug development strategy and decision-making.
引用
收藏
页码:21 / 32
页数:12
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