7.15 FDA certification of new drugs. Pharmaceutical compa- nies 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 confi- dently certify the safety of the drug to potential consumers. a. If the new drug testing were to be placed in a test of hy- pothesis 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 3 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 im- portant that a or ß be small? Explain.

Calculus For The Life Sciences
2nd Edition
ISBN:9780321964038
Author:GREENWELL, Raymond N., RITCHEY, Nathan P., Lial, Margaret L.
Publisher:GREENWELL, Raymond N., RITCHEY, Nathan P., Lial, Margaret L.
Chapter10: Matrices
Section10.EA: Extended Application Contagion
Problem 2EA
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7.15 FDA certification of new drugs. Pharmaceutical compa-
nies 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 confi-
dently certify the safety of the drug to potential consumers.
a. If the new drug testing were to be placed in a test of hy-
pothesis 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 ß 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 im-
portant that a or ß be small? Explain.
Transcribed Image Text:7.15 FDA certification of new drugs. Pharmaceutical compa- nies 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 confi- dently certify the safety of the drug to potential consumers. a. If the new drug testing were to be placed in a test of hy- pothesis 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 ß 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 im- portant that a or ß be small? Explain.
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