Bio Equivalence

Question 1

What is the usual acceptable range for bioequivalence?

Answer 1

0.8 - 1.25

Question 2

For drugs with a narrow therapeutic index, how would the acceptable bioequivalence range change?

Answer 2

Range would become more narrow - 0.9 - 1.11

Question 3

Why is it the market leader that is most commonly used for comparison in cross over tests?

Answer 3

Because it has been on the market the longest, has lots of data and is likely the product that most patients are currently on