Journal of Bioequivalence & Bioavailability

Overview of submission of summary Bioequivalence data for ANDAs

2^nd World Congress on Bioavailability & Bioequivalence: Pharmaceutical R & D Summit-2011 and International Conference on Pharmaceutics & Novel Drug Delivery Systems

06-08 June 2011, Las Vegas, USA

Ethan Stier

Scientific Tracks Abstracts: JBB

Abstract:

T he Food and Drug Administration (FDA) amended its regulations on the submission of bioequivalence data to require an abbreviated new drug application (ANDA) applicant to submit data from all bioequivalence (BE) studies the applicant conducts on a drug product formulation submitted for approval. In the past, ANDA applicants submitted BE studies demonstrating that a generic product meets bioequivalence criteria in order for FDA to approve the ANDA, but have not typically submitted additional BE studies conducted on the same drug product formulation, such as studies that do not show that the product meets these criteria. In some cases, fi rms may conduct pilot studies on formulations other than the same drug product formulation. Th e presentation will focus on how to determine if a formulation is considered to be a ?same drug product formulation? and, if so, how to submit the study in the ANDA

Biography :

Ethan M. Stier, R.Ph., Ph.D., is currently acting Deputy Director in the Division of Bioequivalence II in the Of fi ce of Generic Drugs, CDER, FDA. Dr. Stier earned his Ph.D. in Pharmaceutics from the University of Michigan and pharmacy degree from the University of Connecticut. His graduate work focused on protein delivery using liposomal delivery. His current research interests focus on the use of computer simulation to predict bioequivalence and on establishing bioequivalence approaches for complex dosage forms