ABSTRACT
INTRODUCTION Biowaiving-that is, approval of a drug product without having to conduct an in vivo bioequivalence (BE) study-is a well-recognized process of reducing regulatory burden. However, it should not be done at the cost of product quality. To date, there are applications of biowaiving that can be utilized to provide regulatory relief without loss of drug product quality. These include:
n Biowaiver for certain class of drugs based on biopharmaceutics classification system (BCS) (1);
n Biowaiver for lower strengths of immediate release (IR) and extended release (ER) dosage forms based on formulation proportionality and similar dissolution profile (2); and
n Biowaiver based on in vitro-in vivo correlation (IVIVC).
