State of the Art
Clinical Pharmacology & Therapeutics (2007) 82, 21–32. doi:10.1038/sj.clpt.6100235; published online 23 May 2007
Model-based Drug Development
R L Lalonde1, K G Kowalski2, M M Hutmacher1, W Ewy2, D J Nichols1, P A Milligan1, B W Corrigan1, P A Lockwood1, S A Marshall1, L J Benincosa1, T G Tensfeldt1, K Parivar1, M Amantea1, P Glue1, H Koide1 and R Miller1
- 1Department of Clinical Pharmacology, Pfizer Global Research and Development, Groton, Ann Arbor, Sandwich, New York, La Jolla, Tokyo
- 2Department of Statistics, Pfizer Global Research and Development, Groton, Ann Arbor, Sandwich, New York, La Jolla, Tokyo
Correspondence: R Lalonde, (richard.lalonde@pfizer.com)
Abstract
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.
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