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

• मुख्य लेखकों: Claudia Miranda (लेखक), Alexis Aceituno (लेखक), Mirna Fernández (लेखक), Gustavo Mendes (लेखक), Yanina Rodríguez (लेखक), Verónica Llauró (लेखक), Miguel Ángel Cabrera-Pérez (लेखक)
• स्वरूप: पुस्तक
• प्रकाशित: MDPI AG, 2021-03-01T00:00:00Z.
• विषय: article
• ऑनलाइन पहुंच: 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...