In Phase I clinical trials, the potential uses and effects of a new drug are determined by which of the following methods?
A) Administering doses to healthy volunteers
B) Administering doses to people with the disease
C) Administering in placebo-controlled design
D) Calculating the risk-to-benefit ratio
A
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Phase I studies allow for the administration of the medication to healthy volunteers to determine safe dosages, routes of administration, absorption, metabolism, excretion, and toxicity. In Phase II studies, a few doses are given to a certain number of subjects with the disease or symptom for which the drug is being studied and responses are compared with those of healthy subjects. Placebo-controlled designs are used in the Phase III studies, in which half of the subjects receive the new drug and half receive the placebo. Calculating the risk-to-benefit ratio is used in Phase II studies to determine whether the potential benefits of the drug outweigh the risks.
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