ICH Guideline for Biopharmaceutics Classification System-Based Biowaiver (M9): Toward Harmonization in Latin American Countries

• Main Authors: Claudia Miranda (Author), Alexis Aceituno (Author), Mirna Fernández (Author), Gustavo Mendes (Author), Yanina Rodríguez (Author), Verónica Llauró (Author), Miguel Ángel Cabrera-Pérez (Author)
• Format: Book
• Published: MDPI AG, 2021-03-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

The biopharmaceutical classification system (BCS) is a very important tool to replace the traditional in vivo bioequivalence studies with in vitro dissolution assays during multisource product development. This paper compares the most recent harmonized guideline for biowaivers based on the biopharma...