Biopharmaceutics Classification System (BCS): Development, Implementation, and Growth

This book provides a comprehensive overview of the Biopharmaceutics Classification System (BCS), with detailed discussion on its benefits, current activities, up-to-date regulatory guidelines, and future developments. The book is divided into three sections. The first part focuses on the development of the BCS framework and covers the basic science behind BCS, US FDA perspective, EMA perspective, Latin American perspective, and WHO perspective. The second section covers implementation in various forms of work and research, with chapters written by scientists from regulatory agencies, industry, and academia. Chapters include innovator and generic industry perspectives, illustrative case studies, FIP and BCS based monographs, and in-vitro permeability methods. The last section focuses on the growth and future of the BCS framework. These chapters cover current research and applications like excipient issues, optimizing dissolution, and extensions like the Biopharmaceutics Drug Disposition Classification System (BDDCS). This section also includes chapters on new science and methodologies and critical evaluation of BCS-based regulations worldwide.