Null hypothesis assumes that the population mean is the same as a target value or another population mean. In equivalence testing, the null hypothesis assumes the population mean differs from a target value or other population mean.
For example, difference between a 2-sample t-test (Hypothesis) and a 2-sample equivalence test can be best illustrated as,
2-sample t-test to test whether the means of two populations are different. The hypotheses for the test are as follows:
Null hypothesis (H0): The means of the two given populations are the same.
Alternative hypothesis (H1): The means of the two given populations are different.
If the p-value for the test is less than alpha (α), then the null hypothesis is rejected and concluded as the means are different.
In contrast, 2-sample equivalence test is used to test whether the means of two populations are equivalent. Equivalence for the test is defined by a range of values that you specify (also called the equivalence interval). The hypotheses for the test are as follows:
· Null hypothesis (H0): The difference between the means is outside equivalence interval. The means are not equivalent.
· Alternative hypothesis (H1): The difference between the means is inside the equivalence interval. The means are equivalent.
If the p-value for the test is less than α, then you reject the null hypothesis and conclude that the means are equivalent.
Small differences between products are not always functionally or practically important. For example, a difference of 1 mg in a 200 mg dose of a drug is unlikely to have any practical effect. When an equivalence test is done we must enter equivalence limits that indicate how large the difference must be to be considered important. Smaller differences, which are within the equivalence limits, are considered unimportant. In this way, an equivalence test evaluates both the practical significance and statistical significance of a difference from the population mean.
To choose between an equivalence test and a standard t-test, consider what needs to be proven or demonstrated.
The objective of hypothesis test is to conclude the samples are different but when we want to prove that the samples are equivalent we use equivalence test.
Equivalence testing is a better approach as compared to usual hypothesis testing when
New food item meant to be a substitute
New generic drug compared to old standard (bioequivalence)
This process makes more sense logically because more samples gives us more power for detecting ‘equivalence’.
An alternative to the two-sample t-test is TOST, designed specifically for bioequivalence testing of pharmaceutical products. It has recently been expanded into broader applications in pharmaceutical science, process engineering, psychology , medicine , chemistry and environmental science.
An equivalence test forces us to identify from a practical perspective how big of a difference is important and puts the burden on the data to reach a conclusion of equivalence.