Answer to Question 1
Correct Answer: 1
Rationale 1: A placebo is an inert substance that has no therapeutic effect and is used as a control.
Rationale 2: A placebo is not a similar drug
Rationale 3: A placebo is generally not another drug.
Rationale 4: A placebo is not an over-the-counter drug
Global Rationale: A placebo is an inert substance that has no therapeutic effect and is used as a control. A placebo is not a similar drug, generally not another drug, and is not an over-the-counter drug.
Answer to Question 2
Correct Answer: 4
Rationale 1: The pharmaceutical company files the NDA.
Rationale 2: The clinical investigators do not determine marketability of the drug.
Rationale 3: Clinical investigators do not determine the cost of the drug.
Rationale 4: Safety is determined by the FDA during the Investigational New Drug Application process.
Global Rationale: During the FDA drug approval process, clinical investigators address concerns on whether or not the drug is safe. Safety is determined by the FDA during the Investigational New Drug Application process. The pharmaceutical company files the NDA. The clinical investigators do not determine marketability of the drug or determine the cost of the drug.