Population PK Modeling Supporting the Aripiprazole Two-Injection Start Regimen in Japanese Patients

Population pharmacokinetic (popPK) modeling and simulation were used to support the regulatory submission of a simplified two-injection start (TIS) regimen for once-monthly aripiprazole long-acting injectable in Japanese patients with schizophrenia or bipolar I disorder. Using data from 1,123 participants across Japanese and non-Japanese clinical trials, the researchers externally validated and updated an existing popPK model and demonstrated similar plasma concentration-time profiles between the TIS and original initiation regimens. The findings illustrate how model-informed drug development can leverage existing clinical evidence to support regulatory decision-making while potentially reducing the need for additional clinical trials.