Pivotal BE Study Archives

Pilot and Pivotal Bioequivalence (BE) Study Strategy for Generics

ByPharma Lesson March 4, 2025March 4, 2025 Reading Time: 2 minutes

Pilot BE Study with Two Dosing Strategies To optimize the formulation before the pivotal BE study, two pilot BE studies are conducted with different dissolution behaviors: Strategy 1: Formulation with Matching Dissolution in Discriminating Media Strategy 2: Formulation with Faster or Slower Dissolution (Depending on Dosage Form) Pilot BE Study Strategy Study Design Dosing Strategies:…