|  | Public Health Safety | Medical Research

What Tests Are Done on New Drugs?

Drugs have to undergo a long series of new tests before they are introduced into a market. Although the exact regulations change from country to country, the U.S. Food and Drug Administration is an example of the sorts of testing required before a drug is legally allowed to be prescribed and sold. These tests require a large amount of money and time, which is why few drugs come out each year.

  1. Pre-Clinical Research Stage

    • The pre-clinical research stage of drug testing involves purification and synthesizing the drug to the point where it's effective enough to be used as a medicine. This drug is then used in a battery of scientific tests, such on types of tissue or on animals. The effects of this are scrutinized by institutional review boards of impartial scientists, who report to the FDA whether it's safe to begin limited-scale human testing of the drug.

    Phase 1 Testing

    • The first phase of clinical studies is the initial tests on humans. This phase examines the very simple effects of a drug on humans such as metabolism, the biological paths it takes, large side effects, and other easily examinable situations. If the drug has an obvious result, this phase is used to determine the efficacy of the drug. Fewer than 100 people are involved in this, to minimize risk.

    Phase 2 Testing

    • Phase 2 clinical trials can be performed only after phase 1 clinical trials have had their results approved by the FDA, because this second phase expands the risk. This phase tests the effect of the drug on the condition it is designed to treat, and it monitors common side effects. The pool of trial patients in phase 2 testing numbers in the hundreds. Phase 2 trials must have their results approved before phase 3 trials can begin.

    Phase 3 Testing

    • Once the first two phases have been finished and approved, phase 3 testing begins. This final phase is used to attempt to determine how safe the drug is in the medium- to long-term, and to find any rare risks or side effects. This is done by testing the drug with several thousand people.

Medical Research - Related Articles