Bioequivalence and Bioequivalency Testing

PROLOGUE This lecture material is covered in one and one-half fiftyminute lecture periods. The primary objectives of the lecture are to: (i) review interpatient and intrapatient pharmacokinetic variability; (ii) introduce the concepts of therapeutic equivalence and bioequivalence; (iii) introduce the current FDA standards on bioequivalence; (iv) introduce the basic approach of bioequivalency testing; (v) provide an example of a clinical study assessing bioequivalence, showing calculations and conclusion regarding bioequivalency; and (vi) discuss the current FDA standards of bioequivalence as they relate to the approval of generic formulations of highly variable drugs and to the interchangeability of formulations of drugs with low therapeutic indices. The overall goal of the lecture is to introduce pharmacy students to bioequivalence and to bioequivalency testing, such that they may appropriately address the concerns of patients regarding generic substitution and appropriately advise physicians regarding the interchangeability of approved drug formulations.