Model‐based Drug Development View Full Text


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Article Info

DATE

2007-07

AUTHORS

R L Lalonde, 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

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. More... »

PAGES

21-32

References to SciGraph publications

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  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1038/sj.clpt.6100235

    DOI

    http://dx.doi.org/10.1038/sj.clpt.6100235

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1043146976

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/17522597


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