What Equivalence Means

Traditional statistics are used in trying to find differences between two products. In the medical field, equivalence has become a goal. For example, a test product is very expensive and another product is inexpensive. The goal is to discover if they are equivalent so the cheaper one can be sold. In these tests, one is trying to determine if the two products are the same within a given tolerance level. Out of pure error, you will find that one product has an advantage over the other, when there is not any difference. 

There are four compenents that must be addressed in evaluating a product, for example, a pre-operative skin preparation:

  • Non-Inferiority- the test product cannot be inferior to the control product
  • Superiority- the test product must be superior to the vehicle product
  • At least 100 subjects per product must have the product applied for this study; and
  • At the final sample time- six hours- all the reduction counts must be equal to or exceed the baseline value for both test and control products. 

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