Publication: JCP: The Journal of Clinical Pharmacology
Abstract
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.
Authors: Antal Martinecz, PhD & Mayumi Hasegawa, PhD, Certara. Yumiko Yamasaki, MSc, Otsuka Pharmaceutical Co., Ltd. Tomohiro Sasaki, PhD, Otsuka Pharmaceutical Co., Ltd. Kazuo Kuwahara, MSc, Otsuka Pharmaceutical Co., Ltd. Ayaka Soga, BS, Otsuka Pharmaceutical Co., Ltd. Kai Yamada, MSc, Otsuka Pharmaceutical Co., Ltd. Satoshi Katayama, MSc, Otsuka Pharmaceutical Co., Ltd. Kenji Maeda, PhD, Otsuka Pharmaceutical Co., Ltd. Takako Ichimura, BS, Otsuka Pharmaceutical Co., Ltd. Yosuke Kawai, MSc, Otsuka Pharmaceutical Co., Ltd.
Published: 2026 年 7 月 7 日
Turning existing clinical data into regulatory evidence
See how Certara’s pharmacometrics experts use population PK modeling and simulation to leverage existing clinical data, bridge evidence across populations, and support regulatory strategies that can reduce the need for additional clinical trials.
