Pilot and Pivotal Bioequivalence (BE) Study Strategy for Generics
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:…