Before a medical treatment can even be tested on humans, animal testing is required. This phase is called pre-clinical testing. Animal testing is governed by three principles: 1) to keep animal use to a minimum but still collect data indicating that the treatment is safe and effective in humans; 2) minimize animal suffering and assure animal welfare as much as possible; 3) replace animal experiments with other alternatives when possible.
Phase I testing is the first step in humans. The purpose is to determine safety and to evaluate side effects. Often people who do not have the disease (healthy individuals) participate in Phase I.
Phase II trials are sometimes divided into Phase IIA and Phase IIB. Sometimes these two sub-phases are combined. Phase II trials further assess dosing and are designed to determine the best drug dose to use and how much of a dose is safe. Phase II studies can also measure efficacy and safety testing in small numbers of participants. Often a treatment must pass Phase II in order to proceed to Phase III.
Sometimes researchers conduct Phase IV trials, after a drug has been approved. These trials collect additional information about the drug or treatment.
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