Global testing of a consensus solubility assessment to enhance robustness of the WHO biopharmaceutical classification system

• Main Authors: Valeria Gigante (Author), Giovanni M. Pauletti (Author), Sabine Kopp (Author), Minghze Xu (Author), Isabel Gonzalez-Alvarez (Author), Virginia Merino (Author), Michelle P. McIntosh (Author), Anita Wessels (Author), Beom-Jin Lee (Author), Kênnia Rocha Rezende (Author), Gerhard K.E. Scriba (Author), Gaurav P. S. Jadaun (Author), Marival Bermejo (Author)
• Format: Book
• Published: International Association of Physical Chemists (IAPC), 2020-10-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

The WHO Biopharmaceutical Classification System (BCS) is a practical tool to identify active pharmaceutical ingredients (APIs) that scientifically qualify for a waiver of in vivo bioequivalence studies. The focus of this study was to engage a global network of laboratories to experimentally quantify...