US Food and Drug Administration (FDA) is in charge of approval of new drugs. Pha
ID: 3216788 • Letter: U
Question
US Food and Drug Administration (FDA) is in charge of approval of new drugs. Pharmaceutical companies need to submit a report demonstrating that their drug is safe and effective, and then FDA will review the report and make the decision of approval or rejection. (a) Formulate the test of hypothesis regarding the safety and effectiveness of a new drug. (b) What error will occur if a safe and effective drug is rejected? What error will occur if an unsafe or ineffective drug approved? (c) Between the two types of errors in (b), which one should FDA be concerned more and hence try to control? Explain your conclusion.Explanation / Answer
a. H0: drug is not safe and effective Vs. Ha: drug is safe and effective.
b. If safe or effective drug is rejected, then one one makes Type II error by incorrectly retaining a false null hypothesis. In case, ineffective or unsafe drug gets approved, one makes Type I error by incorrectly rejecting true null hypothesis.
c. FDA should try to control Type II error, where, safe and effective drug is rejected.
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