Pilot vs Pivotal Study Designs in BA/BE Trials: Regulatory Roles, Objectives, and Planning
Pilot vs Pivotal Study Designs in BA/BE Trials: Regulatory Roles, Objectives, and Planning Understanding the Role of Pilot and Pivotal Studies in BA/BE Development Introduction: Why Differentiating Pilot and Pivotal Studies Matters In bioavailability and bioequivalence (BA/BE) development, the journey from formulation development to regulatory submission typically involves two key study types: the pilot study…