Answer to Question 1
C
Feedback:
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.
Answer to Question 2
D
Feedback:
Older adults are prone to adverse drug reactions because of a decrease in the number of receptors needed for drug distribution. BSA does not change appreciably with age and bowel motility slows with age. Polypharmacy is a valid concern, but this phenomenon does not primarily involve distribution.
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