New and Integrated Approaches to Successful Accelerated Drug Development


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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  1. 1.

    DeMasi JA. Trends in drug development: costs, times, and risks. Drug Inf J. 1995;29:375–384.

    Article  Google Scholar 

  2. 2.

    Lin JH, Lu AY. Role of pharmacokinetics and metabolism in drug discovery and development. Pharmacol Rev. 1997;49:403–449.

    CAS  PubMed  Google Scholar 

  3. 3.

    DeMasi JA, Hansen RW, Grabowski HG, Lasagna L. Research and development costs for new drugs by therapeutic category. Pharma Econ. 1995;7:152–169.

    Article  Google Scholar 

  4. 4.

    Kleinberg ML, Wanke LA. New approaches and technologies in drug design and discovery. Am J Health SystPharm. 1995;52:1323–1336;1341–1343.

    CAS  Article  Google Scholar 

  5. 5.

    Andersen Consulting. Pharmaceutical & Medical Products Executive Briefing. Drug Discovery: Innovation and Productivity. 1998:1–26.

    Google Scholar 

  6. 6.

    Bugg CE, Carson WM, Montgomery JA. Drugs by design. Sci Am. 1993;269:92–98.

    CAS  Article  Google Scholar 

  7. 7.

    Ziai MR, Beer B. Making business sense of science with rational drug design. Pharm Exec. 1990;10:40, 42, 44, 46.

    Google Scholar 

  8. 8.

    Hayes AH, Jr. Safety considerations in product development. Drug Saf. 1990;5(suppl):24–26.

    Article  Google Scholar 

  9. 9.

    Establishment of Prescription Drug User Fee Rates for Fiscal Year 1998. Federal Register. 1997;62(236):64849–64851.

    Google Scholar 

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Correspondence to Anthony Clemento MA.

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Clemento, A. New and Integrated Approaches to Successful Accelerated Drug Development. Ther Innov Regul Sci 33, 699–710 (1999).

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Key Words

  • Clinical testing
  • Accelerated drug development
  • Drug discovery
  • Preclinical testing
  • Product development
  • Research