The Calculus Behind Generic Drug Equivalence
Michael A. Jones
American Mathematical Society
Motivated by an interview on National Public Radio's Science Friday, I look at the calculus behind the bioequivalence of generic and name brand drugs. To show bioequivalence, the Federal Drug Administration (FDA) requires a statistical comparison of three values related to the concentration of the drugs. These three values are related to calculus. I show that there is good reason why the FDA considers these values, as any two of the three is enough to recover the concentration of the drug over time for an orally taken, single-compartment drug. The results hinge on applications of the Lambert W function. We revisit the biostatistics problem and explain how bioequivalence is determined in practice.
This talk is based on a paper of the same title, co-authored with Stanley R. Huddy of Farleigh Dickinson University.