Drug approval testing

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Drugs

Drug type

Designer drugs Dissociative drug Hallucinogenic drugs Nonprescription drugs Nootropic drugs Pharmaceutical drug Psychedelic drug Psychoactive drug Prescription drugs

Drug usage

Adverse drug reaction Drug abstinance Drug administration methods Drug allergies Drug discrimination Drug induced congenital disorders Drug interactions Drug metabolism Epidemiology of drug use Recreational drug use

Drug abuse

Codependency Drug abuse liability Drug addiction Drug dependency Drug dosages Drug induced hallucinations Drug laws Drug legalization Drug overdoses Drug sensitivity Drug tolerance Drug usage attitudes Drug withdrawal Laxative abuse Intravenous drug use Illegal drug distribution Needle exchange programs Needle sharing Poly drug abuse

Drug treatment

DANOS Drug abuse psychology Drug abuse prevention Drug augmentation Drug education Drug rehabilitation Drug self administration Drug therapy Drug usage screening Psychopharmacology Self medication Side effects (drug)

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.

In the United States, the FDA approves drugs.

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^{[citation needed]}.

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.

See also

• Abbreviated New Drug Application
• Dietary supplement
• Drug discovery
• Drug design
• Drug development
• Drug withdrawal
• Folk remedy
• Homeopathy
• Herbology
• Medical prescription
• Patent medicine
• Prescription drugs
• Toxicity

External links

• ClinicalTrials.gov from US National Library of Medicine
• ICH Website
• FDA Website
• [http://psych.fullerton.edu/mwhite/475pdf/475DrugDevelopment.pdf Outline of FDA procedure.
• ClinicalTrials.gov from US National Library of Medicine
• Careers in Clinical Research
• Clinical Research Services
• Clinical Research Companies Listings
• Clinical Research Abbreviations and Acronyms
• Clinical Research Glossary / Definitions
• List of Food and Drugs Regulatory Agencies

[[Category:clinical research]