A Survey of the Regulatory Requirements for BCS-Based Biowaivers for Solid Oral Dosage Forms by Participating Regulators and Organisations of the International Generic Drug Regulators Programme

• Main Authors: Joy Elizabeth van Oudtshoorn (Author), Alfredo García-Arieta (Author), Gustavo Mendes Lima Santos (Author), Christopher Crane (Author), Clare Rodrigues (Author), Craig Simon (Author), Ji Myoung Kim (Author), Sang Aeh Park (Author), Yusuke Okada (Author), Ryosuke Kuribayashi (Author), Chantal Pfäffli (Author), Arno Nolting (Author), Iván Omar Calderón Lojero (Author), Zulema Rodríguez Martínez (Author), Wen-Yi Hung (Author), April C. Braddy (Author), Nancy Arciniegas Leal (Author), Diego Gutierrez Triana (Author), Mitch Clarke (Author), Peter Bachmann (Author)
• Format: Book
• Published: Frontiers Media S.A., 2018-03-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Purpose:  The Biopharmaceutics Classification System (BCS) based biowaiver is a scientific model which enables the substitution of in vivo bioequivalence studies with in vitro data as evidence of therapeutic equivalence subject to certain conditions. Despite being based on the same principles, BCS-b...