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Not Just for Safety Anymore?

Arch Intern Med. 2006;166:1440-1441.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

New drugs are always being developed to fulfill unmet therapeutic needs or to improve efficacy and reduce toxicity of current therapies. Drug development takes a great deal of time, effort, and money. It is estimated that of approximately 10 000 drugs considered promising in the initial screening assay results, fewer than 10 make it to a clinical trial, and only 2 are eventually approved by the Food and Drug Administration (FDA). Advances in combinatorial chemistry, computer design, and structural biology have accelerated the identification of new targets and drugs, yet the process is still cumbersome and lengthy.

DRUG DEVELOPMENT

Following the identification of a drug, several in vitro and in vivo systems are used to define the activity and toxicity of the drug. The science of developing quantitative estimates of drug toxicity has been well-established, and these data form the basis for submitting the investigation of new drug applications to the FDA. On . . . [Full Text of this Article]

PHASE 1 STUDIES

AUTHOR INFORMATION
Janardan Khandekar, MD; Melin Khandekar, MD, PhD

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Arch Intern Med. 2006;166(14):1446-1448.
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