A Survey of the Regulatory Requirements for the Waiver of In Vivo Bioequivalence Studies of Generic Products in Certain Dosage Forms by Participating Regulators and Organisations of the International Pharmaceutical Regulators Programme

• Main Authors: Alfredo Garcia Arieta (Author), Craig Simon (Author), Andrew Tam (Author), Gustavo Mendes Lima Santos (Author), Eduardo Agostinho Freitas Fernandes (Author), Zulema Rodríguez Martínez (Author), Clare Rodrigues (Author), Sang Aeh Park (Author), JaYoung Kim (Author), Kwansoo Kim (Author), Ryosuke Kuribayashi (Author), Aya Myoenzono (Author), Kohei Shimojo (Author), Chantal Walther (Author), Matthias S. Roost (Author), Wen-Yi Hung (Author), Li-feng Hsu (Author), Christopher Crane (Author), April C. Braddy (Author), Joy van Oudtshoorn (Author), Diego Alejandro Gutierrez Triana (Author), Erwin Guzmán Aurela (Author), Ben Jones (Author), Henrike Potthast (Author), Ivana Abalos (Author)
• Format: Book
• Published: Frontiers Media S.A., 2021-03-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

The requirements to waive in vivo bioequivalence studies for immediate release solid oral dosage forms based on the Biopharmaceutics Classifications System (BCS) are well known, and biowaivers[1] for other types of oral dosage forms based on pre-defined criteria may also be acceptable. Similarly, bi...