What is the current knowledge on the topic? ○ After the initial approval of talazoparib, a new soft gelatin capsule (SGC) formulation was developed and bridging with the initial commercial hard capsule (HC) formulation was needed. For post-approval formulation bridging, the demonstration of both AUC and Cmax equivalence in a bioequivalence (BE) study and evaluation of food effect (FE) are generally required.