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Research in Progress
Drug Development
Ever Wonder Why Drugs Fail?
What is the fate of a pharmaceutical drug? According to the Alliance Pharmaceutical Corporation’s website (http://www.allp.com/drug_dev.htm), it takes approximately twelve years for an experimental drug to progress from the lab to the patient. Drugs generally go through the following six phases: preclinical testing (laboratory and animal studies); phases I, II, and III of clinical trials; Food and Drug Administration (FDA) review and approval; and phase IV, additional post-marketing testing required by the FDA.
The technology news weblog “In the Pipeline” (http://www.corante.com/pipeline/), describes how some drugs fail at different points during the six aforementioned phases:
46% of all drug failures result from a lack of efficacy in phase II. Regarding failure at other phases, the weblog states that a phase I failure is “painful,” but a phase III failure “can affect the future of the whole [pharmaceutical] company.”
17% fail due to animal toxicity (after preclinical testing).
16% fail due to human toxicity.
7% fail due to “bad ADME properties.” ADME is pharmacology lingo for Absorption, Distribution, Metabolism, and Excretion, the processes that occur in the patient’s body once he or she takes the recommended dose of the drug. According to the weblog, researchers have a terrible time predicting all four ADME properties in humans.
7% fail due to faulty commercial decisions (bad marketing, etc.)
The remaining 7% fail due to a variety of other reasons.
Last Modified: 04/12/2007
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