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FDA certification of new drugs. According to Chemical
Chapter 7, Problem 15E(choose chapter or problem)
FDA certification of new drugs. According to Chemical Marketing Reporter, pharmaceutical companies spend $15 billion 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?
b. Given the choice of null and alternative hypotheses in part a, describe Type I and Type II errors in terms of this application. Define \(\alpha\) and \(\beta\) in terms of this application.
c. If the FDA wants to be very confident that the drug is safe before permitting it to be marketed, is it more important that \(\(\alpha\) and \(\beta\)\) be small? Explain.
Questions & Answers
QUESTION:
FDA certification of new drugs. According to Chemical Marketing Reporter, pharmaceutical companies spend $15 billion 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?
b. Given the choice of null and alternative hypotheses in part a, describe Type I and Type II errors in terms of this application. Define \(\alpha\) and \(\beta\) in terms of this application.
c. If the FDA wants to be very confident that the drug is safe before permitting it to be marketed, is it more important that \(\(\alpha\) and \(\beta\)\) be small? Explain.
ANSWER:Step 1 of 4
According to Chemical Marketing Reporter, pharmaceutical companies spend $15 billion 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.