Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2007 Jul;82(1):21-32.
doi: 10.1038/sj.clpt.6100235. Epub 2007 May 23.

Model-based drug development

R L Lalonde  1 , K G Kowalski, M M Hutmacher, W Ewy, D J Nichols, P A Milligan, B W Corrigan, P A Lockwood, S A Marshall, L J Benincosa, T G Tensfeldt, K Parivar, M Amantea, P Glue, H Koide, R Miller
Affiliations
Review

Model-based drug development

R L Lalonde et al. Clin Pharmacol Ther. 2007 Jul.

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.

PubMed Disclaimer

MeSH terms