Before the FDA Approves an IND for Human Testing of a New

question 9

Multiple Choice

Before the FDA approves an IND for human testing of a new drug,

• A)several hundred volunteers have been exposed to the drug.
• B)the drug has been tested in at least two species of nonhuman animals.
• C)the drug's effectiveness has been proven.
• D)the drug must be marketed in another country.

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Definitions:

Law of Averages

A layman's term often misused to suggest that a future event is likely to occur to balance out a statistical deviation, though not a formal statistical principle.

Independent Events

Two or more events whose outcomes do not affect each other's probabilities of occurring.

Positive Difference

The result of subtracting a smaller number from a larger number, ensuring a non-negative result.

Fair 6-Sided Dice

A classic dice with six faces, each showing a number from one to six, where each number has an equal likelihood of appearing on a roll.