Goals and Objectives

This symposium aims to offer up-to-date information on the oral absorption of drugs and to consider the better regulatory standatd for controlling the quality of oral drug products. This symposium consists of 4 sessions, starting with the session for scientific insights on the intestinal drug absorption to predict oral BA and drug–drug interactions in human, then the second session for cutting-edge technologies for oral formulation to achieve the high and constant absorption. In the third session, concept and application of in vitro-in vivo correlation (IVIVC) and Biopharmaceutics Classification System (BCS) are presented to streamline the development of oral drug products and biowaive human BE study. Finally, current status of the regulatory system for oral drug products in EU, USA, Korea and Japan are presented to discuss about the international standard of regulation. In order to develop the efficient and safe medicines for oral use, experts of science and technology of oral drug absorption must know the regulatory system for controlling the quality of oral drug products. Reversely, regulatory persons must understand the underlying science and technology to guarantee the safety and efficacy of final products. Therefore, final goals of this symposium are, Understanding up-to-date Science, Technology and Regulation relating to oral BA and BE to be the real expert of oral drug development. Understanding the current status of regulation to control the quality of oral dug products and proposing the international standard.