In developing a generic drug, it is necessary for a manufacturer of biopharmaceutical products to show equivalence
Question:
In developing a generic drug, it is necessary for a manufacturer of biopharmaceutical products to show equivalence to the current product. The variable of interest is the absorption rate of the product. The current product has an absorption rate of 18 mg/hr. If the new generic product has an absorption rate that is within 0.50 mg/hr of this value, it will be considered equivalent. A random sample of 20 units of product is available, and the sample mean and standard deviation of absorption rate are 18.22 mg/hr and 0.92 mg/hr, respectively.
(a) State the appropriate hypotheses that must be tested to demonstrate equivalence.
(b) What are your conclusions using α = 0.05?
Step by Step Answer:
Applied Statistics And Probability For Engineers
ISBN: 9781118539712
6th Edition
Authors: Douglas C. Montgomery, George C. Runger