# Question: When a new drug is formulated the pharmaceutical company must

When a new drug is formulated, the pharmaceutical company must subject it to lengthy and involved testing before receiving the necessary permission from the Food and Drug Administration (FDA) to market the drug. The FDA requires the pharmaceutical company to provide substantial evidence that the new drug is safe for 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 a and b 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 a or b be small? Explain.

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 a and b 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 a or b be small? Explain.

**View Solution:**## Answer to relevant Questions

Refer to the U.S. Department of Transportation study of the level of cell phone use by drivers while they are in the act of driving a motor passenger vehicle, presented in Exercise 7.119 (p. 342). Recall that in a random ...Refer to Exercise 8.153. a. In the context of the problem, define a Type II error. b. Calculate b for the test described in part a of Exercise 8.153, assuming that the true mean is µ = 3.1 ppm. c. What is the power of ...Sketch the sampling distribution of (p̂1 - p̂2) based on independent random samples of n1 = 100 and n2 = 200 observations from two binomial populations with probabilities of success p1 = .1 and p2 = .5, respectively. Find the appropriate values of n1 and n2 (assume that n1 = n2) needed to estimate (µ1 - µ2) with a. A sampling error equal to 3.2 with 95% confidence. From prior experience, it is known that σ1 ≈ 15 and σ2 ≈ 17. b. ...Independent random samples were selected from each of two normally distributed populations, n1 = 6 from population 1 and n2 = 4 from population 2. The data are shown in the following table and saved in the LM9_96 ...Post your question