A Proposal of Conducting Bioequivalence Trials with Gastric pH Modulators for Two Oral Formulations Demonstrating Different Dissolution Profiles at Elevated pH

• Main Authors: Hao Zhu (Author), Xiaomei Chen (Author), Mariam Ahmed (Author), Yaning Wang (Author), Qi Liu (Author), Ramana S. Uppoor (Author), Colleen Kuemmel (Author), Mehul Mehta (Author)
• Format: Book
• Published: Wiley, 2019-11-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

In this paper, a special case for bioequivalence evaluation of oral formulations is discussed. Drug formulations with different forms of active moieties (e.g., free base and salt) may yield different dissolution characteristics and, thus, differ in absorption at elevated gastric pH. However, routine...