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A new medication for the treatment of Alzheimer's disease is being administered to a group of subjects with the disease. The subjects receiving this medication are unaware of whether they are being administered the medication or whether they are receiving a placebo. This testing occurs in which phase of the drug approval process?
A)Phase I
B)Phase II
C)Phase III
D)Phase IV
Source  Download
Abrams' Clinical Drug Therapy: Rationales for Nursing Practice
Edition: 10th
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In Phase III, the drug is given to a larger and more representative group of subjects. In double-blind, placebo-controlled designs, half of the subjects receive the new drug and half receive a placebo (an inactive substance similar in appearance to the actual drug), with neither subjects nor researchers knowing which subjects receive which formulation. In Phase I, a few doses are given to a certain number of healthy volunteers to determine safe dosages, routes of administration, absorption, metabolism, excretion, and toxicity. In Phase II, 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. In Phase IV, the FDA evaluates the data from the first three phases for drug safety and effectiveness, allows the drug to be marketed for general use, and requires manufacturers to continue monitoring the drug's effects.

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