Traditionally, the development of a new drug from discovery to market takes 10 to 15 years and costs hundreds of millions of dollars. Accelerated drug development, therefore, is of critical importance to both maximizing return on this investment and bringing drugs for unmet medical needs to patients as rapidly as possible. New structure-based development strategies are being combined with integrated, multidisciplinary approaches to speed the processes of physicochemical and pharmacological characterization, toxico-logical investigation, and clinical testing. The process of accelerated drug development, however, presents unique challenges as well as opportunities.
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Clemento, A. New and Integrated Approaches to Successful Accelerated Drug Development. Ther Innov Regul Sci 33, 699–710 (1999) doi:10.1177/009286159903300306
- Clinical testing
- Accelerated drug development
- Drug discovery
- Preclinical testing
- Product development