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

• Автори: Joy Elizabeth van Oudtshoorn (Автор), Alfredo García-Arieta (Автор), Gustavo Mendes Lima Santos (Автор), Christopher Crane (Автор), Clare Rodrigues (Автор), Craig Simon (Автор), Ji Myoung Kim (Автор), Sang Aeh Park (Автор), Yusuke Okada (Автор), Ryosuke Kuribayashi (Автор), Chantal Pfäffli (Автор), Arno Nolting (Автор), Iván Omar Calderón Lojero (Автор), Zulema Rodríguez Martínez (Автор), Wen-Yi Hung (Автор), April C. Braddy (Автор), Nancy Arciniegas Leal (Автор), Diego Gutierrez Triana (Автор), Mitch Clarke (Автор), Peter Bachmann (Автор)
• Формат: Книга
• Опубліковано: Frontiers Media S.A., 2018-03-01T00:00:00Z.
• Предмети: article
• Онлайн доступ: 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...