Question

FDA certification of new drugs. Pharmaceutical companies spend billions of dollars per year on research and development of new drugs. The pharmaceutical company must subject each new drug to lengthy and involved testing before receiving the necessary permission from the Food and Drug Administration (FDA) to market the drug. The FDA’s policy is that the pharmaceutical company must provide substantial evidence that a new drug is safe prior to receiving FDA approval, so that the FDA can confidently certify the safety of the drug to potential consumers.

a. If the new drug testing were to be placed in a test of hypothesis framework, would the null hypothesis be that the drug is safe or unsafe? The alternative hypothesis?

Short answer

1. The null hypothesis would be that the drug is unsafe and the alternative hypothesis would be that the drug is safe.

Step-by-step solution

Testing of hypothesis

A statistical hypothesis test is a tool of making statistical decision using experimental data. The hypothesis is an assumption which is tested to check whether the inference drawn from the sample data stand true for the entire population or not.

Specifying the null hypothesis

The null hypothesis would be that the drug is unsafe if the new drug testing were to be placed in a test.

Specifying the alternative hypothesis

The alternative hypothesis would be that the drug is safe if the new drug testing were to be placed in a test.