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In many jurisdictions before a drug can be prescribed, it must undergo an extensive approval process. This process involves first testing the drug on animals or in medical labs. If found to be safe by the approving authority and approved for the next phase of study, the drug is then tested for safety and effectiveness in humans (clinical trials), first in small groups then on increasingly larger numbers.
The drug manufacturer then files a Drug Application to the appropriate authority which reviews the application and either approves or rejects it.
The U.S. and Canadian systems of new drug approvals are perhaps the most rigorous in the world. On average, it costs a company $359 million to get one new medicine from the laboratory to the pharmacist's shelf, according to a February 1993 report by the Congressional Office of Technology Assessment. It takes 12 years on average for an experimental drug to travel from lab to medicine chest. Only five in 5,000 compounds that enter preclinical testing make it to human testing. Only one in five of these tested in people is approved.
Testing for psychological effects
As it becomes increasingly clear that many medications, often prescribed to treat physical conditions, have extensive side effects affecting various aspects of cognitive functioning, including executive functioning, memory loss etc. it is important that the testing protocols for all drugs prior to approval monitors these areas of performance.
- Abbreviated New Drug Application
- Dietary supplement
- Drug discovery
- Drug design
- Drug development
- Drug withdrawal
- Folk remedy
- Medical prescription
- Patent medicine
- Prescription drugs
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