Current Bioavailability and Bioequivalence Requirements and Regulations

Abstract

AbstractThe 1977 Bioavailability/Bioequivalence Regulations formalized the position and thinking of the Food and Drug Administration with regard to bioavailability of drug products marketed in the United States. The regulations defined the terminology involved, set forth criteria for waiver of in vivo bioavailability studies and listed the drugs that would require bioavailability/bioequivalence studies. The regulations also delineated the general approaches for determining bioavailability, laid down guidelines for conducting in vivo bioavailability studies for conventional dosage forms, combination drug products, and controlled release drug products; set forth criteria and evidence to establish a bioequivalence requirement and described the types of bioequivalence requirements. Over the last few years, a number of presentations have been made by the officials of the Agency to describe and explain the regulations at various forums. I am sure that most of you are quite familiar with the various aspects of t...