Biostatistics For Dummies

Chapter 16

Feeling Noninferior (Or Equivalent)

In This Chapter

Demonstrating the absence of an effect in your data

Testing for bioequivalence, therapeutic noninferiority, and absence of harmful effects

Many statistical tests let you determine whether two things are different from each other, like showing that a drug is better than a placebo, or that the blood concentration of some enzyme is higher in people with some medical condition than in people without that condition. But sometimes you want to prove that two (or more) things are not different. Here are three examples I refer to throughout this chapter:

Bioequivalence: You’re developing a generic formulation to compete with a name-brand drug, so you have to demonstrate that your product is bioequivalent to the name-brand product; that is, that it puts essentially the same amount of active ingredient into the bloodstream.

Therapeutic noninferiority: You want to show that your new treatment for some disease is no worse than the current best treatment for that disease.

Absence of harmful effects: Your new drug must demonstrate ...