Designing Bioequivalence Studies for Modified Release Products: Regulatory and Strategic Considerations
Designing Bioequivalence Studies for Modified Release Products: Regulatory and Strategic Considerations How to Design Bioequivalence Trials for Modified Release Formulations Introduction: The Complexity of Modified Release Bioequivalence Modified Release (MR) formulations, including sustained release (SR), extended release (ER), and controlled release (CR), provide distinct therapeutic advantages such as reduced dosing frequency and minimized side effects….