The Requirements for Additional Strength Biowaivers for Immediate Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities

• Main Authors: Christopher Crane (Author), Gustavo Mendes Lima Santos (Author), Eduardo Agostinho Freitas Fernandes (Author), Craig Simon (Author), Andrew Tam (Author), Diego Gutierrez Triana (Author), Henrike Potthast (Author), Ryosuke Kuribayashi (Author), Yusuke Okada (Author), Aya Myoenzono (Author), Ivan Omar Calderon (Author), zulema Rodriguez (Author), ben Jones (Author), Sang Aeh Park (Author), So Young Eum (Author), Clare Rodrigues (Author), Joy van Oudsthoorn (Author), Arno Nolting (Author), Chantal Walther (Author), Matthias S Roost (Author), Wen-yi Hung (Author), April C Braddy (Author), Alfredo Garcia-Arieta (Author)
• Format: Book
• Published: Frontiers Media S.A., 2020-08-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

In relation to the registration of generic products, waivers of in vivo bioequivalence studies (biowaivers) are considered in three main cases: certain dosage forms for which bioequivalence is self-evident (e.g. intravenous solutions), biowaivers based on the Biopharmaceutics Classification System a...