Designing Bioequivalence Studies for Locally Acting Drugs: Regulatory and Clinical Considerations
Designing Bioequivalence Studies for Locally Acting Drugs: Regulatory and Clinical Considerations How to Design BE Studies for Locally Acting Drug Products Introduction: Why Locally Acting Drugs Need Special Study Designs Unlike systemically absorbed drugs where bioequivalence (BE) is established through pharmacokinetic (PK) parameters like Cmax and AUC, locally acting drug products require unique BE study…