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Monday, November 25, 2002Biomedical Breakthroughs: The Current Drug Development Process
Pharmaceutical research and development can be divided into three major tasks: discovery comes up with chemicals that show promise in changing something about the problem under study. Preclinical development refines them into compounds that might actually work. Clinical trials test the compounds on humans to see if they work. Then the compound needs to receive government regulatory approval.
Discovery current happens in two steps. First biologists study how a disease functions at multiple levels. Then, chemists try to find compounds that stop the disease from occurring. Different compounds are then tested in animals to determine if they work without side effects. The primary killer of lead compounds occurs when the compound binds to many proteins not just the single protein causing the problem.
FDA regulations mandate the structure of clinical trials. Phase I examines safety in a small population, usually 20 to 100 people for one year. Phase II established that the drug has some beneficial effects, determines the dosage needed for that effect and confirms safety in larger numbers. Phase II enrolls 100 to 300 people for two years. Phase III proves the beneficial side effect is real and not a fluke by testing it in hundreds or thousands of patients over two years or more.4:31:51 PM
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