A manufacturer of a pharmaceutical product is developing a generic drug and must show its the equivalence

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A manufacturer of a pharmaceutical product is developing a generic drug and must show its the equivalence to the current product. The variable of interest is the activity level of the active ingredient. The current product has an activity level of 100. If the new generic product has an activity level that is within 2 units of this value, it will be considered equivalent. A random sample of 10 units of product is available, and the sample mean and standard deviation of absorption rate are 96 and 1.5, respectively.

(a) State the appropriate hypotheses that must be used to demonstrate equivalence.

(b) What are your conclusions using α = 0.05?

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Applied Statistics And Probability For Engineers

ISBN: 9781118539712

6th Edition

Authors: Douglas C. Montgomery, George C. Runger

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