Premium
Model‐based Drug Development
Author(s) -
Lalonde R L,
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
Publication year - 2007
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/sj.clpt.6100235
Subject(s) - drug development , drug , pharmacology , medicine , computational biology , computer science , biology
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. Clinical Pharmacology & Therapeutics (2007) 82 , 21–32. doi: 10.1038/sj.clpt.6100235 ; published online 23 May 2007