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

• मुख्य लेखकों: Hao Zhu (लेखक), Xiaomei Chen (लेखक), Mariam Ahmed (लेखक), Yaning Wang (लेखक), Qi Liu (लेखक), Ramana S. Uppoor (लेखक), Colleen Kuemmel (लेखक), Mehul Mehta (लेखक)
• स्वरूप: पुस्तक
• प्रकाशित: Wiley, 2019-11-01T00:00:00Z.
• विषय: article
• ऑनलाइन पहुंच: 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...