Single vs Multiple Dose Bioequivalence Trials: Design, Challenges, and Regulatory Considerations
Single vs Multiple Dose Bioequivalence Trials: Design, Challenges, and Regulatory Considerations Comparing Single-Dose and Multiple-Dose Designs in Bioequivalence Trials Introduction: Why Dosing Strategy Matters in BA/BE Trials In bioequivalence (BE) trials, the decision to conduct a single-dose or multiple-dose study impacts not only the study duration and complexity but also its scientific validity and regulatory…